TPLC - Total Product Life Cycle

• Device: wrap, sterilization
• Regulation Description: Sterilization wrap.
• Product Code: FRG
• Regulation Number: 880.6850
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	2
	SUBSTANTIALLY EQUIVALENT - KIT	1
1.  K012931  GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION ...
2.  K120542  CARDINAL HEALTH DURABLUE STERILIZATION WRAP
3.  K123289  DURABLUE STERILIZATION WRAP
4.  K983299  ALLEGIANCE GENESIS CONTAINER SYSTEM
5.  K983719  BIOSHIELD EXPRESS STERILIZATION WRAP
6.  K990300  SUPRASHIELD EXPRESS STERILIZATION WRAP
7.  K993871  BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERIL ...
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ADVANCED STERILIZATION PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP
	SUBSTANTIALLY EQUIVALENT	6
ARJO
	SUBSTANTIALLY EQUIVALENT	3
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BEMIS HEALTH CARE
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	3
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	7
1.  K012931  GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION ...
2.  K120542  CARDINAL HEALTH DURABLUE STERILIZATION WRAP
3.  K123289  DURABLUE STERILIZATION WRAP
4.  K983299  ALLEGIANCE GENESIS CONTAINER SYSTEM
5.  K983719  BIOSHIELD EXPRESS STERILIZATION WRAP
6.  K990300  SUPRASHIELD EXPRESS STERILIZATION WRAP
7.  K993871  BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERIL ...
CASE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	8
CONMED
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	4
KENDALL
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
KIMBERLY-CLARK CORP.
	SUBSTANTIALLY EQUIVALENT	10
LAC MAC, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MANAN MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
MEDCARE
	SUBSTANTIALLY EQUIVALENT	1
MEDCO INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL ACTION INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIKMARK, INC.
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
MEDIN CORP.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	4
PROPPER MFG
	SUBSTANTIALLY EQUIVALENT	1
RILEY MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGMA
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TRINITY
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
TSO3 INC.
	SUBSTANTIALLY EQUIVALENT	1
VYGON CORP.
	SUBSTANTIALLY EQUIVALENT	1
WINNER INDUSTRIES (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	0	0	0	0	1
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Kimberly-Clark Corporation	II	Mar-26-2013