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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wrap, sterilization
Product CodeFRG
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BH MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200 LLC
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU ZHANDE MEDICAL SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KENPAX INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MDK (SHANGHAI) MEDICAL PACKING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
OWENS & MINOR (O&M) HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 1
OWENS & MINOR (O&M) HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
OWENS& MINOR HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QIANJIANG KINGPHAR MEDICAL PACKAGING & PRINTING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAFE SECURE PACKING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGMA MEDICAL SUPPLIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIGMA MEDICAL SUPPLIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SOLIDENCE SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STERILERIGHT PACKAGING MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TURBETT SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
WIPAK OY
  SUBSTANTIALLY EQUIVALENT 6
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 22 22
2019 10 10
2020 21 21
2021 9 9
2022 4 4
2023 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Jan-21-2021
2 Steris Corporation II Feb-27-2018
3 TURBETT SURGICAL, LLC II May-18-2022
4 Turbett Surgical, Inc. II Jan-30-2023
5 Turbett Surgical, Inc. II Aug-04-2022
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