Obstetrics/Gynecology Device Classification Codes
4434 FDA 510(k) clearances across 256 product codes.
HIS
Class 2
HET
Class 2
Laparoscope, Gynecologic (And Accessories)
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MQL
Class 2
Media, Reproductive
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HGX
Class 2
Pump, Breast, Powered
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NUC
Class 2
Lubricant, Personal
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HGM
Class 2
System, Monitoring, Perinatal
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HEB
Class 2
Tampon, Menstrual, Unscented
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HIF
Class 2
Insufflator, Laparoscopic
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HIH
Class 2
Hysteroscope (And Accessories)
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HHD
Class 1
Pad, Menstrual, Unscented
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HIL
Class 2
Tampon, Menstrual, Scented, Scented-Deodorized
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LKF
Class 2
Cannula, Manipulator/Injector, Uterine
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HHT
Class 2
Spatula, Cervical, Cytological
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HIB
Class 2
Speculum, Vaginal, Nonmetal
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HIR
Class 2
Perineometer
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KNG
Class 2
Monitor, Ultrasonic, Fetal
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HHL
Class 2
Pad, Menstrual, Scented, Scented-Deodorized
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KNA
Class 2
Instrument, Manual, Specialized Obstetric-Gynecologic
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HIG
Class 2
Insufflator, Hysteroscopic
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HEX
Class 2
Colposcope (And Colpomicroscope)
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HGI
Class 2
Electrocautery, Gynecologic (And Accessories)
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MQF
Class 2
Catheter, Assisted Reproduction
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HHR
Class 2
Laser, Surgical, Gynecologic
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KNF
Class 2
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
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MQG
Class 2
Accessory, Assisted Reproduction
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HHK
Class 2
Curette, Suction, Endometrial (And Accessories)
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MQK
Class 2
Labware, Assisted Reproduction
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LHQ
Class 1
System, Telethermographic (Adjunctive Use)
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HHW
Class 2
Pessary, Vaginal
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HFW
Class 2
Clamp, Umbilical
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HGL
Class 2
Transducer, Ultrasonic, Obstetric
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MQE
Class 2
Needle, Assisted Reproduction
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OTP
Class 3
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
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HDB
Class 2
Extractor, Vacuum, Fetal
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HEM
Class 2
Imager, Ultrasonic Obstetric-Gynecologic
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HDR
Class 2
Cap, Cervical
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MFD
Class 2
Cannula, Intrauterine Insemination
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HGY
Class 1
Pump, Breast, Non-Powered
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KNC
Class 2
Table, Obstetric (And Accessories)
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KXO
Class 2
Monitor, Pressure, Intrauterine
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HFX
Class 2
Clamp, Circumcision
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HHI
Class 2
System, Abortion, Vacuum
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MQH
Class 2
Microtools, Assisted Reproduction (Pipettes)
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HCZ
Class 2
Forceps, Surgical, Gynecological
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MOL
Class 2
Condom, Synthetic
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HFB
Class 1
Forceps, Biopsy, Gynecological
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HFM
Class 2
Monitor, Uterine Contraction, External (For Use In Clinic)
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LTZ
Class 2
Condom With Nonoxynol-9
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MQJ
Class 2
Micromanipulators And Microinjectors, Assisted Reproduction
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HIO
Class 1
Sampler, Amniotic Fluid (Amniocentesis Tray)
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HDC
Class 2
Tenaculum, Uterine
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HGP
Class 2
Electrode, Circular (Spiral), Scalp And Applicator
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HEW
Class 2
Culdoscope (And Accessories)
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HHE
Class 2
Cup, Menstrual
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HIN
Class 2
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
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KOH
Class 1
Instrument, Manual, General Obstetric-Gynecologic
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HED
Class 1
Douche Apparatus, Vaginal, Therapeutic
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HES
Class 2
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
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HCY
Class 1
Curette, Uterine
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HDF
Class 1
Speculum, Vaginal, Metal
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HDY
Class 2
Dilator, Cervical, Hygroscopic-Laminaria
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HFC
Class 2
Aspirator, Endocervical
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HDA
Class 2
Forceps, Obstetrical
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HHM
Class 1
Sound, Uterine
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OQY
Class 2
Intrauterine Tamponade Balloon
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HDX
Class 2
Dilator, Vaginal
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HEE
Class 2
Set, Anesthesia, Paracervical
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HFE
Class 2
Brush, Endometrial
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HFG
Class 2
Coagulator, Laparoscopic, Unipolar (And Accessories)
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HFN
Class 2
Transducer, Pressure, Intrauterine
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MAA
Class 2
Monitor, Fetal Doppler Ultrasound
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MRX
Class 2
System, Assisted Reproduction Laser
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PEB
Class 2
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
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IYM
Class 3
System, Telethermographic, Infrared
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PBQ
Class 2
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
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HDD
Class 2
Table, Obstetrical, Ac-Powered (And Accessories)
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HEL
Class 2
Monitor, Heart Rate, Fetal, Ultrasonic
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HFI
Class 2
Coagulator, Culdoscopic (And Accessories)
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KXZ
Class 3
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
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MSC
Class 2
Barrier, Std, Oral Sex
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OSP
Class 2
Uterine Electromyographic Monitor
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HDQ
Class 1
Dilator, Cervical, Fixed Size
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HGE
Class 1
Amniotome
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HHF
Class 1
Remover, Intrauterine Device, Contraceptive, Hook-Type
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MLS
Class 2
Labor And Delivery Kit
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PYT
Class 2
Device, Fertility Diagnostic, Contraceptive, Software Application
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HFF
Class 2
Aspirator, Endometrial
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HGH
Class 2
Cannula, Suction, Uterine
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HIC
Class 2
Speculum, Vaginal, Nonmetal, Fiberoptic
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KYA
Class 1
System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
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LQK
Class 2
Home Uterine Activity Monitor
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MOV
Class 2
Catheters, Salpingography
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ONX
Class 2
Ovarian Adnexal Mass Assessment Score Test System
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PCF
Class 2
Sampler, Endocervical
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PWJ
Class 2
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
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HDP
Class 2
Elevator, Uterine
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HEK
Class 2
Monitor, Heart Sound, Fetal, Ultrasonic
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HEP
Class 2
Monitor, Blood-Flow, Ultrasonic
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HFO
Class 2
Recorder, Pressure, Intrauterine
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HGF
Class 2
Source, Abortion Unit, Vacuum
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HGW
Class 2
Sampler, Blood, Fetal
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KXP
Class 2
Stent, Vaginal
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MKO
Class 2
Falloposcope
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PON
Class 2
Catheter, Balloon, Dilation Of Cervical Canal
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HDW
Class 2
Diaphragm, Contraceptive (And Accessories)
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HEI
Class 2
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
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HFD
Class 2
Washer, Endometrial
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KXQ
Class 2
Vibrator For Therapeutic Use, Genital
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OBB
Class 2
Kit, Conception-Assist, Home Use
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PBH
Class 2
Embryo Image Assessment System, Assisted Reproduction
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PMU
Class 2
Containment System, Laparoscopic Power Morcellation, With Instrument Port
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QFT
Class 2
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
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QYZ
Class 2
At Home Intravaginal Insemination System
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FHG
Class 2
Bell, Circumcision
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FHJ
Class 2
Shield, Circumcision
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HDG
Class 1
Speculum, Vaginal, Metal, Fiberoptic
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HDL
Class 1
Retractor, Vaginal
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HGC
Class 1
Clamp, Uterine
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HGN
Class 1
Stethoscope, Fetal
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HGS
Class 2
Catheter, Intrauterine And Introducer
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HHO
Class 2
Screw, Fibroid, Gynecological
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HHP
Class 2
Table, Obstetrical, Manual (And Accessories)
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KNE
Class 2
Set, Anesthesia, Obstetric
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KXN
Class 2
Monitor, Cardiac, Fetal
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MOK
Class 2
Vaginoscope And Accessories
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MPU
Class 2
Source, Chemiluminescent Light
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MTW
Class 2
System, Water, Reproduction, Assisted, And Purification
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NBV
Class 2
Device, Engorgement, Clitoral
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NHM
Class 2
Sheet, Recording, Breast Examination
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NKA
Class 2
System, Documentation, Breast Lesion
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PAI
Class 3
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
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PTE
Class 2
Endoscopic Morcellator Gastroenterology
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PWI
Class 2
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
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HDJ
Class 1
Scissors, Umbilical
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HFJ
Class 2
Prosthesis, Fallopian Tube
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HFK
Class 2
Mold, Vaginal
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HFL
Class 2
Drain, Cervical
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HGD
Class 1
Applicator, Vaginal
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HGG
Class 2
Controller, Abortion Unit, Vacuum
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HGK
Class 2
Endoscope, Fetal Blood Sampling (And Accessories)
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HGZ
Class 2
Heater, Perineal, Direct Contact
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HHJ
Class 2
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
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KNB
Class 2
Instrument, Destructive, Fetal, Obstetric
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LBX
Class 2
Pelvimeter, Internal
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LHM
Class 1
System, Thermographic, Liquid Crystal
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LHZ
Class 1
Viscometer, Mucus, Cervical
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LLW
Class 2
Laser, Neodymium:Yag For Gynecologic Use
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MDG
Class 2
System, Intrafallopian Cannula
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MLT
Class 2
Pelvic Exam Kit
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MPT
Class 2
Contraception Calculator
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NBZ
Class 2
Clamp And Cutter, Umbilical
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NUQ
Class 1
Pad, Menstrual, Reusable
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OYO
Class 2
Culture, Intravaginal, Assisted Reproduction
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PFJ
Class 2
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
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PGK
Class 2
Cannula, Injector, Uterine, Endometrial Biopsy
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PGT
Class 2
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
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PUB
Class 2
Accessory, Assisted Reproduction, Exempt
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PWB
Class 2
Fetal Head Elevator
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PWK
Class 2
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
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QPD
Class 2
Personal Lubricant Ring
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QUJ
Class 2
Automated Cryopreservation Storage System
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HDE
Class 1
Hook, Fibroid, Gynecological
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HDH
Class 1
Needle, Cerclage, Gynecological
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HDI
Class 2
Hook, Destructive, Obstetrical
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HDK
Class 1
Scissors, Episiotomy
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HDM
Class 1
Packer, Uterine
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HDN
Class 3
Dilator, Cervical, Expandable
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HDO
Class 3
Valve, Tubal Occlusion
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HDT
Class 3
Device, Intrauterine, Contraceptive And Introducer
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HDZ
Class 2
Knife, Cervical Cone
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HEC
Class 1
Insufflator, Vaginal
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HEG
Class 2
Set, Anesthesia, Pudendal
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HEH
Class 3
Chamber, Decompression, Abdominal
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HEJ
Class 2
Monitor, Hemic Sound, Ultrasonic
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HEN
Class 2
Caliper, Fetal Head, Ultrasonic
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HEO
Class 3
Analyzer, Data, Obstetric
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HEQ
Class 2
Monitor, Pressure, Arterial, Fetal, Ultrasonic
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HER
Class 1
Pelvimeter, External
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HEZ
Class 2
Endoscope, Transcervical (Amnioscope)(And Accessories)
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HFA
Class f
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
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HFH
Class 2
Coagulator, Hysteroscopic (And Accessories)
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HFP
Class 2
Monitor, Phonocardiographic, Fetal
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HFY
Class 3
Band, Tubal Occlusion
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HFZ
Class 2
Craniotribe
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HGA
Class 2
Cranioclast
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HGB
Class 3
Clip, Tubal Occlusion
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HGO
Class 3
Monitor, Electroencephalographic, Fetal (And Accessories)
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HHA
Class 2
Heater, Perineal, Radiant, Non-Contact
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HHG
Class 3
Dilator, Cervical, Vibratory
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HHN
Class 2
Cleidoclast
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HHQ
Class 3
System, Abortion, Metreurynter-Balloon
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HHS
Class 3
Transcervical Contraceptive Tubal Occlusion Device
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HHX
Class 2
Holograph, Fetal, Acoustical
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HII
Class 3
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
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HIM
Class 2
Electrocautery, Endoscopic And Accessories
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HIQ
Class 3
Electrode, Clip, Fetal Scalp (And Applicator)
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KND
Class 2
Heater, Perineal
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KNH
Class 3
Laparoscopic Contraceptive Tubal Occlusion Device
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LHP
Class 3
System, Telethermographic (Sole Diagnostic Screen)
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LHR
Class 3
System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)
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LXE
Class 2
Doppler, Fetal, Ultrasound
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LZL
Class 3
Micro-Condom
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MBU
Class 2
Single-Use Internal Condom
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MOH
Class 2
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
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MQI
Class 2
Microtool Fabrication, Assisted Reproduction
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MTX
Class 1
Microscope And Microscope Accessories, Reproduction, Assisted
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NKC
Class 1
Tubing/Tubing With Filter, Insufflation, Laparoscopic
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NMG
Class 2
Forceps, Biopsy, Gynecological, Reprocessed
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NMH
Class 2
Laparoscope And Accessories, Gynecologic, Reprocessed
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NMI
Class 1
Laparoscopic Insufflator And Accessories, Reprocessed
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NNB
Class 2
Needle, Reproduction, Assisted, Reprocessed
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NRC
Class 1
Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile
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NUR
Class 1
Pad, Menstrual, Intralabial
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NVT
Class 1
Tubing And Tubing/Filter Fits
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NWV
Class 1
Laparoscopic Accessories, Gynecologic
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NWW
Class 1
Hysteroscope Accessories
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OBY
Class 3
Condom, Female, Animal Tissue
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OCQ
Class 2
Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence
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OHC
Class 2
Obstetrical Vacuum Delivery Kit
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OHD
Class 2
Gynecological Laparoscopic Kit
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OHE
Class 2
Forensic Evidence Sexual Assault Kit
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OHF
Class 2
Culdocentesis Kit
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OHG
Class 2
Circumcision Tray
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OHH
Class 2
Breast Pump Kit
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OHL
Class 2
Pap Smear Kit
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OHM
Class 2
Cesarean Section Tray
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OJF
Class 2
Hysterectomy Kit
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OKU
Class 1
Emergency Obstetrical Kit
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OKV
Class 2
Obstetrical Kit
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OKW
Class 2
Seminal Fluid Collection Kit
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OKX
Class 2
Trocar Kit
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OKY
Class 2
Cytology Kit
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OKZ
Class 2
Endometrial Sampling Kit
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OOA
Class 2
Hemorrhoid Prevention Pressure Wedge
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OSV
Class 2
Insufflator, Endoscopic Vessel Harvesting
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PKN
Class 2
Dilator, Cervical, Synthetic, Osmotic
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PNU
Class 2
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
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PTZ
Class 2
Colposcope (And Colpomicroscope), Exempt
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PUA
Class 2
Tenaculum, Uterine, Exempt
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PUC
Class 2
Microtools, Assisted Reproduction (Pipettes), Exempt
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PUD
Class 2
Labware, Assisted Reproduction, Exempt
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PVR
Class 2
D&C Tray
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PVS
Class 2
Fetal Blood Sampling Kit (Excludes Hiv Testing)
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PVT
Class 1
Maternity Kit
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PVU
Class 2
Obstetrical Anesthesia Kit
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PVV
Class 2
Paracervical Anesthesia Kit
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PVW
Class 2
Pudendal Anesthesia Kit
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PVX
Class 2
Vaginal Examination Tray
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PWA
Class 1
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
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QAG
Class 2
Endoscopic Electrosurgical Clip Cutting System
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QHZ
Class 1
Seal, Cervical, Mechanical, Unpowered
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QKH
Class 2
Assisted Reproduction Laminar Flow Workstation
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QKI
Class 2
Media, Reproductive, Exempt
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QQR
Class 2
Circumcision Device With Stapler
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QRZ
Class 2
External Condom For Anal Intercourse Or Vaginal Intercourse
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SIM
Class 2
Gynecologic Power Morcellator And Containment System
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