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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 2026-07-02

HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology

Applicant O&M Halyard, Inc.

K number K261897

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FRG 2026-05-28

Dukal Crepe Paper Sterilization Wrap

Applicant Dukal, LLC

K number K252823

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FRG 2026-05-18

HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

Applicant O&M Halyard, Inc.

K number K253454

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FRG 2026-01-28

Sterilization Pouch/Roll

Applicant Sterivic Medical Co., Ltd.

K number K251347

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FRG 2025-12-12

Self-Seal Sterilization Pouch and Roll

Applicant Guangdong Maidi Medical Co., Ltd.

K number K251177

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FRG 2025-10-31

Chex-All Sterilization Pouches and Tubes

Applicant Propper Manufacturing Co., Inc.

K number K250306

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FRG 2025-06-26

Sterilization Pouch and Roll

Applicant Yichang Xinxin Paper Products Co., Ltd.

K number K243179

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FRG 2025-06-06

GCI Sterilization Wrappers

Applicant George Courey, Inc.

K number K250321

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FRG 2025-04-25

Self Sealing Sterilization Pouches

Applicant Wellmed Dental Medical Supply Co., Ltd.

K number K243721

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FRG 2025-04-04

Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)

Applicant Turbett Surgical

K number K250011

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FRG 2025-02-24

Sterilization Package/Reel

Applicant Anqing Clean Dental Instrument Technology Co., Ltd.

K number K241565

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FRG 2025-02-21

Medicom Sterilization Pouch and Reel

Applicant Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.

K number K243431

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FRG 2025-02-21

Sterilization Pouches and Reels

Applicant Shanghai Jianzhong Medical Packaging Co., Ltd.

K number K242898

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FRG 2024-11-04

CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)

Applicant Comercializadora Brever

K number K240438

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FRG 2024-10-16

Safe Secure Sterilization Pouches and Rolls

Applicant Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

K number K242839

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FRG 2024-10-07

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Applicant Primed Medical Products, Inc.

K number K242208

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FRG 2024-09-18

Perpak™ Sterilization Tyvek Pouch

Applicant Km Corp.

K number K241123

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FRG 2024-09-17

Medline Reusable Sterilization Wrappers

Applicant Medline Industries, LP

K number K234132

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FRG 2024-09-16

HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap

Applicant O&M Halyard, Inc.

K number K234050

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FRG 2024-08-07

HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)

Applicant O&M Halyard, Inc.

K number K240330

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FRG 2024-06-21

Medicom Sterilization Wrap

Applicant Medicom Group, Inc.

K number K240862

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FRG 2024-06-07

Steriking® Pouch for Robotic Instruments

Applicant Wipak OY

K number K232625

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FRG 2024-05-24

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Applicant Primed Medical Products, Inc.

K number K233777

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FRG 2024-03-22

Dukal SMS Sterilization Wrap

Applicant Dukal, LLC

K number K233262

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FRG 2023-12-07

Reliance® Fusion Sterilization Wraps

Applicant Ahlstrom-Munksjo Nonwovens, LLC

K number K230137

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FRG 2023-09-07

Steriking® LT-Blueline Pouches with Tyvek®

Applicant Wipak OY

K number K231999

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FRG 2023-09-07

Steriking® LT-Blueline Pouches with Tyvek®

Applicant Wipak OY

K number K231996

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FRG 2023-08-25

Sterilization Wrap

Applicant Wuhan Zonsen Medical Products Co., Ltd.

K number K223600

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FRG 2023-08-07

Vis-U-All Low Temperature Sterilization Pouches

Applicant STERIS Corporation

K number K231500

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FRG 2023-05-09

Tyvek Roll with CI for STERLINK Sterilizer

Applicant Plasmapp Co,., Ltd.

K number K223025

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FRG 2023-03-23

Sterilization Wrap

Applicant Kenpax International Limited

K number K222151

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FRG 2023-02-13

Sterilization Pouch and Roll

Applicant Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.

K number K221875

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FRG 2023-01-04

Steriking LT-Blueline Pouches with Tyvek

Applicant Wipak OY

K number K221379

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FRG 2022-12-22

SteriKing LT-Blueline Pouches with Tyvek

Applicant Wipak OY

K number K221377

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FRG 2022-10-06

Gemini Sterilization Wrap

Applicant Medline Industries, LP

K number K220365

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FRG 2022-09-09

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

Applicant Steris

K number K222440

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FRG 2022-08-03

Solidence Multipockets

Applicant Solidence Surgical Corporation

K number K191131

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FRG 2022-07-27

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap

Applicant Owens & Minor (O&M) Halyard, Inc.

K number K214007

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FRG 2022-05-05

Steriking Packaging for Medical Devices

Applicant Wipak OY

K number K221016

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FRG 2022-03-14

CareGUARD Sterilization Wrap

Applicant Care Essentials Pty, Ltd.

K number K213907

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FRG 2022-03-10

Sterilization Wraps

Applicant Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

K number K220133

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FRG 2022-01-23

Steiking Packaging for Medical Devices

Applicant Wipak OY

K number K210810

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FRG 2021-11-01

SterileRight sterilization pouch and roll

Applicant Sterileright Packaging Mfg., Inc.

K number K212338

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FRG 2021-10-22

Tyvek(R) Roll with CI for STERLINKTM Sterilizer

Applicant Plasmapp Co,., Ltd.

K number K212198

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FRG 2021-05-19

Turbett Instrument Pod

Applicant Turbett Surgical, Inc.

K number K202593

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FRG 2021-04-23

SIGMA Sterilization Pouch and Roll

Applicant Sigma Medical Supplies Corporation

K number K202462

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FRG 2020-11-12

Tyvek Sterilization Pouches with Chevron Seal

Applicant Andersen Sterilizers, Inc.

K number K200336

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FRG 2020-11-12

Sterisheet Sterilization Wrap

Applicant Andersen Sterilizers, Inc.

K number K200335

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FRG 2020-04-30

Turbett Instrument Pod

Applicant Turbett Surgical, Inc.

K number K200240

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FRG 2020-04-15

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

Applicant Weihai Xingtai Packaging Products Co., Ltd.

K number K193561

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FRG 2020-01-24

Gemini Titan Sterilization Wrap

Applicant Medline Industries, Inc.

K number K192641

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FRG 2019-10-10

Halyard ONE-STEP* Sterilization Wrap

Applicant Owens & Minor (O&M) Halyard, Inc.

K number K192147

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FRG 2019-10-10

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)

Applicant Mdk (Shanghai) Medical Packing Co., Ltd.

K number K182184

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FRG 2019-08-19

Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

Applicant Weihai Xingtai Packaging Products Co., Ltd.

K number K183356

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FRG 2019-07-09

Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted

Applicant Tianchang Jiarui Packaging Material Co., Ltd.

K number K181957

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FRG 2019-06-11

JAMBRO Single Core A Sterilization wrap

Applicant Jiangsu Zhande Medical Supplies Co., Ltd.

K number K182656

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FRG 2019-03-22

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

Applicant Owens & Minor Halyard, Inc.

K number K181959

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FRG 2019-03-01

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Applicant STERIS Corporation

K number K183401

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FRG 2019-01-03

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Applicant STERIS Corporation

K number K183297

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FRG 2019-01-03

Safe Secure Sterilization Pouches and Rolls

Applicant Safe Secure Packing Co., Ltd.

K number K180139

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FRG 2018-12-11

Cardinal Health Sterilization Wrap

Applicant Cardinal Health200, LLC

K number K181174

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FRG 2018-08-03

BH Sterilization Pouch

Applicant Bh Medical Products Co., Ltd.

K number K172280

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FRG 2018-06-06

Sterilization Pouch/Roll Made with Tyvek

Applicant Sigma Medical Supplies Corporation

K number K180672

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FRG 2018-06-05

SIGMA Sterilization Pouch and Roll

Applicant Sigma Medical Supplies Corp.

K number K180661

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FRG 2018-02-09

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Applicant STERIS Corporation

K number K172749

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FRG 2017-11-01

Sterisheet Sterilization Wrap

Applicant Andersen Sterilizers, Inc.

K number K170437

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FRG 2017-10-27

Tyvek Sterilization Pouches with Chevron Seal

Applicant Andersen Sterilizers, Inc.

K number K170429

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FRG 2017-10-13

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

Applicant Pms Tibbi Cihazlar Teknolojisi San VE Tic AS

K number K162362

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FRG 2017-08-25

Standard Supreme Sterilization Wrapper

Applicant Standard Textile Co., Inc.

K number K172207

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FRG 2017-06-29

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

Applicant Ahlstrom Nonwovens, LLC

K number K171533

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FRG 2017-06-23

Gemini Sterilization Wrap

Applicant Medline Industries, Inc.

K number K162993

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FRG 2017-04-28

Self Sealing Sterilization Pouches

Applicant Tianchang Jiarui Packaging Material Co., Ltd.

K number K162258

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FRG 2017-04-20

Cardinal Health Sterilization Wrap

Applicant Cardinal Health200, LLC

K number K161910

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FRG 2017-02-10

SteriTite Containers System & MediTray Products

Applicant Case Medical, Inc.

K number K161415

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FRG 2016-11-18

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

Applicant Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti

K number K160595

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FRG 2016-11-04

Barrier Supreme Sterilization Wrapper

Applicant Standard Textile Co., Inc.

K number K162162

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FRG 2016-08-04

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

Applicant Safe Secure Packaging Co., Ltd.

K number K153540

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FRG 2016-07-27

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

Applicant Ahlstrom Nonwovens, LLC

K number K160755

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FRG 2016-07-22

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Applicant STERIS Corporation

K number K160908

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FRG 2016-07-07

Gemini Sterilization Wrap

Applicant Medline Industries, Inc.

K number K152564

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FRG 2016-06-01

Gemini Bonded Sterilization Wrap

Applicant Medline Industries, Inc.

K number K152458

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FRG 2016-01-15

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

Applicant Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std

K number K152669

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FRG 2016-01-14

Turbett Surgical Container

Applicant Turbett Surgical, LLC

K number K153025

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FRG 2013-12-13

DURABLUE STERILIZATION WRAP

Applicant Cardinal Health-Medical Products and Services

K number K132060

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FRG 2013-08-20

KIMGUARD ONE STEP STERILIZATION WRAP

Applicant Kimberly-Clark Health Care

K number K113806

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FRG 2013-06-18

DURABLUE STERILIZATION WRAP

Applicant Cardinal Health200, LLC

K number K130927

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FRG 2013-02-28

DURABLUE STERILIZATION WRAP

Applicant Cardinal Health-Medical Products and Services

K number K123289

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FRG 2013-01-31

GEMINI STERILZATION WRAP

Applicant Medline Industries, Inc.

K number K113353

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FRG 2013-01-23

DURABLUE STERILIZATION WRAP

Applicant Cardinal Health200, LLC

K number K123857

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FRG 2012-09-26

DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION

Applicant Cardinal Health200, LLC

K number K122507

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FRG 2012-08-24

ARJORAD STERILE WRAP

Applicant Arjo Wiggins Medical, Inc.

K number K110954

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FRG 2012-08-08

FLASHPAK

Applicant Symmetry Medical

K number K113776

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FRG 2012-06-22

KIMGUARD ONE-STEP STERILIZATION WRAP

Applicant Kimberly-Clark Corp.

K number K112805

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FRG 2012-06-13

DURABLUE STERILIZATION WRAP

Applicant Cardinal Health200, LLC

K number K120658

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FRG 2012-06-01

CARDINAL HEALTH DURABLUE STERILIZATION WRAP

Applicant Cardinal Health-Medical Products and Services

K number K120542

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FRG 2012-02-07

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS

Applicant Safe Secure Packaging Co., Ltd.

K number K112591

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FRG 2012-01-24

STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS

Applicant Case Medical, Inc.

K number K112904

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FRG 2012-01-20

DURABLUE STERILIZATION (AMSCO V-PRO) WRAP

Applicant Cardinal Health200, LLC

K number K112918

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FRG 2012-01-19

KIMGUARD SMART-FOLD* STERILIZATION WRAP

Applicant Kimberly-Clark Corp.

K number K112300

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FRG 2011-10-20

DURA BLUE STERILIZATION WRAP

Applicant Cardinal Health200, LLC

K number K112283

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