Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Wrap, Sterilization

FDA product code FRG · 303 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.6850
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-02 – 2026-07-02

FRG 2011-10-20

DURA BLUE STERILIZATION WRAP

Applicant Cardinal Health200, LLC

K number K112211

View details →

FRG 2011-08-02

SIGMA STERILIZATION POUCH & ROLL

Applicant Sigma Medical Supplies Corp.

K number K102158

View details →

FRG 2011-07-20

STERI-DENT, STERI-SURE

Applicant Cpac, Inc.

K number K110867

View details →

FRG 2011-06-06

TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS

Applicant Advanced Sterilization Products

K number K103210

View details →

FRG 2011-01-14

84E SERIES SINGLE PLY WRAPPER

Applicant Lac Mac, Ltd.

K number K102864

View details →

FRG 2010-12-22

HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS

Applicant Hinson and Hale Medical Technologies, Inc.

K number K102783

View details →

FRG 2010-07-27

AESCULAP STERILCONTAINER S

Applicant Aesculap, Inc.

K number K093493

View details →

FRG 2010-05-11

AESCULAP STERILCONTAINER S

Applicant Aesculap

K number K093649

View details →

FRG 2010-02-24

STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS

Applicant Case Medical, Inc.

K number K090068

View details →

FRG 2009-11-02

KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600

Applicant Kimberly-Clark Corp.

K number K092167

View details →

FRG 2009-09-03

KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600

Applicant Kimberly-Clark Corp.

K number K091685

View details →

FRG 2009-05-01

KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600

Applicant Kimberly-Clark Corp.

K number K082554

View details →

FRG 2009-03-27

KIMGUARD ONE-STEP STERILIZATION WRAP

Applicant Kimberly-Clark Corp.

K number K082177

View details →

FRG 2008-12-05

STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS

Applicant Case Medical, Inc.

K number K080558

View details →

FRG 2008-05-30

TSO3 OZONE STERILIZATION WRAP

Applicant Tso3, Inc.

K number K080198

View details →

FRG 2007-12-27

SELF SEAL STERILIZATION POUCH

Applicant Shanghai Jianzhong Medical Packaging Co., Ltd.

K number K071886

View details →

FRG 2007-10-16

VIS-U-ALL II HEAT-SEAL POUCH AND TUBING

Applicant STERIS Corporation

K number K071087

View details →

FRG 2007-06-08

STERILIZATION POUCH WITH INDICATORS

Applicant Winner Industries (Shenzhen) Co., Ltd.

K number K062704

View details →

FRG 2006-12-05

ARJOWRAP 47/100 AND 47/88

Applicant Arjo Wiggins Medical, Inc.

K number K062100

View details →

FRG 2006-11-17

AESCULAP STERILCONTAINER SYSTEM

Applicant Aesculap

K number K062510

View details →

FRG 2006-10-16

CONMED LINVATEC INSTRUMENT STERILIZATION TRAY

Applicant Conmed Linvatec

K number K052992

View details →

FRG 2006-02-27

GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES

Applicant Granton Medical , Ltd.

K number K052665

View details →

FRG 2006-02-15

AESCULAP STERILCONTAINER SYSTEM

Applicant Aesculap, Inc.

K number K053389

View details →

FRG 2005-06-03

WAGNER STERISET STERILIZATION CONTAINER

Applicant Wagner GmbH

K number K041096

View details →

FRG 2004-12-13

REUSABLE STERILCONTAINER FILTER MODEL #JK090

Applicant Aesculap, Inc.

K number K041623

View details →

FRG 2004-12-06

AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER

Applicant Aesculap

K number K040865

View details →

FRG 2004-11-17

TIDI BRAND STERILIZATION WRAP

Applicant Banta Healthcare Group, Ltd.

K number K042580

View details →

FRG 2004-04-16

PACKAGING TRAY AND COMPONENTS

Applicant Vygon Us, LLC

K number K040707

View details →

FRG 2003-05-09

STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS

Applicant Case Medical, Inc.

K number K022978

View details →

FRG 2003-04-14

PROTEC-TOP, STERIDENT, BENTO

Applicant Ronpak, Inc.

K number K031022

View details →

FRG 2003-04-07

STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM

Applicant Case Medical, Inc.

K number K023614

View details →

FRG 2003-03-25

STERILIZATION CASES AND TRAYS

Applicant Carr Metal Products, Inc.

K number K023658

View details →

FRG 2003-03-21

STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI

Applicant Case Medical, Inc.

K number K030853

View details →

FRG 2003-03-04

SELF SEAL STERILIZATION POUCH

Applicant Granton Medical , Ltd.

K number K023025

View details →

FRG 2002-08-28

APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER

Applicant Advanced Sterilization Products

K number K013003

View details →

FRG 2002-08-20

GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM

Applicant Allegiance Healthcare Corp.

K number K012931

View details →

FRG 2002-04-01

RE-USABLE STERILIZATION POUCH / BAG

Applicant Quality Products of Montana

K number K013715

View details →

FRG 2001-12-07

METAPAK MULTI-PURPOSE INSTRUMENT TRAY

Applicant Riley Medical, Inc.

K number K993535

View details →

FRG 2001-05-08

MEDLINE STERISET STERILIZATION CONTAINER

Applicant Medline

K number K010825

View details →

FRG 2001-01-23

MEDLINE STERILIZATION WRAP

Applicant Medline Industries, Inc.

K number K002968

View details →

FRG 2000-08-04

ALLEGIANCE GENESIS CONTAINER SYSTEM

Applicant Allegiance Healthcare Corp.

K number K983299

View details →

FRG 2000-04-21

BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP

Applicant Allegiance Healthcare Corp.

K number K993871

View details →

FRG 2000-01-27

STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL

Applicant Case Medical, Inc.

K number K991023

View details →

FRG 1999-12-16

PARAPOST SYSTEM STERILIZABLE ORGANIZER

Applicant Coltene/Whaledent, Inc.

K number K993835

View details →

FRG 1999-12-06

BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE

Applicant Coltene/Whaledent, Inc.

K number K993255

View details →

FRG 1999-08-25

BIOSHIELD EXPRESS STERILIZATION WRAP

Applicant Allegiance Healthcare Corp.

K number K983719

View details →

FRG 1999-07-09

TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE

Applicant Tuttnauer U.S.A Co, Ltd.

K number K990761

View details →

FRG 1999-04-05

GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH

Applicant Global Healthcare, Inc.

K number K990567

View details →

FRG 1999-02-10

SUPRASHIELD EXPRESS STERILIZATION WRAP

Applicant Allegiance Healthcare Corp.

K number K990300

View details →

FRG 1999-01-14

DENTAL STERLIZATION TRAY/CASSETTE

Applicant Brasseler USA I, L.P.

K number K983223

View details →

FRG 1997-12-18

STERITITE SEALED CONTAINERS MODEL SCO4Q

Applicant Case Medical, Inc.

K number K974638

View details →

FRG 1997-11-13

CARR RIGID CONTAINER SYSTEM

Applicant Carr Metal Products, Inc.

K number K972138

View details →

FRG 1997-06-24

SECURE-WRAP (TM) STERILIZATION WRAP

Applicant American Threshold Industries, Inc.

K number K971483

View details →

FRG 1997-05-06

CYGNUS INSTRUMENT PROTECTORS

Applicant Madison Polymeric Engineering

K number K964256

View details →

FRG 1997-03-11

PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)

Applicant Surgicot, Inc.

K number K962605

View details →

FRG 1997-03-05

BIOPSY TRAY

Applicant Medcare Medical Group, Inc.

K number K970152

View details →

FRG 1996-06-10

JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY

Applicant J.J. Skinner, Inc.

K number K961227

View details →

FRG 1996-04-12

CPR TOTAL HIP PACK

Applicant Custom Pack Reliability

K number K960213

View details →

FRG 1996-04-12

CPR TOTAL KNEE PACK

Applicant Custom Pack Reliability

K number K960211

View details →

FRG 1996-04-12

CPR ORTHO HAND PACK

Applicant Custom Pack Reliability

K number K960210

View details →

FRG 1996-04-12

CPR DRESSING CHANGE TRAY

Applicant Custom Pack Reliability

K number K960206

View details →

FRG 1996-03-28

CPR SUTURE REMOVAL KIT

Applicant Custom Pack Reliability

K number K960238

View details →

FRG 1996-03-28

CPR BASIC SET-UP TRAY

Applicant Custom Pack Reliability

K number K960208

View details →

FRG 1996-03-21

LACERATION TRAY

Applicant Medco Instruments, Inc.

K number K960520

View details →

FRG 1996-02-27

CPR LACERATION TRAY

Applicant Custom Pack Reliability

K number K960207

View details →

FRG 1996-02-27

G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY

Applicant GE Medical Systems

K number K960204

View details →

FRG 1996-02-21

G.E. STERILE PUNCTURE TRAY

Applicant GE Medical Systems

K number K960202

View details →

FRG 1996-02-21

G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY

Applicant GE Medical Systems

K number K960201

View details →

FRG 1996-02-21

G.E. STERILE, STANDARD BIOPSY TRAY

Applicant GE Medical Systems

K number K960141

View details →

FRG 1996-02-21

RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY

Applicant Contour Fabricators of Florida, Inc.

K number K955688

View details →

FRG 1996-02-21

RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY

Applicant Contour Fabricators of Florida, Inc.

K number K955686

View details →

FRG 1996-02-21

RNS STERILE DISPOSABLE PUNCTURE TRAY

Applicant Contour Fabricators of Florida, Inc.

K number K955678

View details →

FRG 1996-01-25

LACERATION TRAY

Applicant Transidyne General Corp.

K number K955658

View details →

FRG 1995-10-02

STERIMED STERIZATION WRAPPER (NON-STERILE)

Applicant Customed, Inc.

K number K953678

View details →

FRG 1995-06-28

NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION

Applicant Products For Medicine

K number K951704

View details →

FRG 1995-03-20

SURGICLA INSTRUMENT KIT

Applicant Medical Action Industries, Inc.

K number K946019

View details →

FRG 1995-03-15

SAFEDWEEL DRESSING CHANGE TRAY

Applicant Becton Dickinson Vascular Access, Inc.

K number K950438

View details →

FRG 1995-03-14

GENT-L-KARE LACERATION TRAYS

Applicant Premium Plastics, Inc.

K number K950850

View details →

FRG 1995-01-30

MAMMOCORE BIOPSY TRAY

Applicant Manan Medical Products, Inc.

K number K943653

View details →

FRG 1994-12-27

SKIN SCRUB TRAY

Applicant Clinical Resources, Inc.

K number K944881

View details →

FRG 1994-12-19

STERISURE STERILIZATION WRAP

Applicant Fiberweb North America, Inc.

K number K944854

View details →

FRG 1994-08-22

SUTURE REMOVAL TRAYS

Applicant Sterile Concepts, Inc.

K number K943090

View details →

FRG 1994-07-14

BIOPSY TRAY

Applicant Cush Medical Products

K number K941645

View details →

FRG 1994-06-10

AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE

Applicant Amsco Sterile Recoveries, Inc.

K number K931875

View details →

FRG 1994-06-10

RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE

Applicant Amsco Sterile Recoveries, Inc.

K number K931874

View details →

FRG 1994-05-23

ORION CENTRAL LINE DRESSING CHANGE TRAY

Applicant Regulatory & Marketing Services, Inc.

K number K941542

View details →

FRG 1994-05-20

BURN DRESSING TRAY

Applicant Medcare Custom Packaging, Inc.

K number K942000

View details →

FRG 1994-05-12

CENTRAL LINE DRESSING CHANGE TRAY

Applicant Clinical Resources, Inc.

K number K941471

View details →

FRG 1994-05-12

DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY

Applicant Clinical Resources, Inc.

K number K941468

View details →

FRG 1994-05-12

WOUND DRESSING KIT

Applicant Clinical Resources, Inc.

K number K941467

View details →

FRG 1994-04-22

SURGICAL INSTRUMENTS KIT

Applicant Clinical Resources, Inc.

K number K941466

View details →

FRG 1994-03-29

HYDRASPUN M STERILIZATION WRAP

Applicant Ahlstrom Dexter

K number K933550

View details →

FRG 1994-03-01

STERILE CENTRAL LINE DRESSING TRAY

Applicant Surgipro, Inc.

K number K934031

View details →

FRG 1994-02-17

ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY

Applicant Sherwood Medical Co.

K number K935238

View details →

FRG 1994-02-10

SKIN SCRUB TRAY

Applicant Cush Medical Products

K number K935742

View details →

FRG 1994-02-10

TRACHEOSTOMY CARE TRAY

Applicant Cush Medical Products

K number K935685

View details →

FRG 1994-02-10

SUTURE REMOVAL TRAY

Applicant Cush Medical Products

K number K935683

View details →

FRG 1994-02-10

LACERATION TRAY

Applicant Cush Medical Products

K number K935682

View details →

FRG 1994-02-10

INCISION/DRAINAGE TRAY

Applicant Cush Medical Products

K number K935681

View details →

FRG 1994-02-07

CUSTOM PLASTIC PACKS

Applicant Associated Medical

K number K935622

View details →

↑