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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device general surgery tray (kit)
Regulation Description Surgical drape and drape accessories.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Product CodeLRO
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT - KIT 3
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 3
ALCON
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GI SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

Device Problems
Foreign material present in device 8
Unknown (for use when the device problem is not known) 3
Device misassembled during manufacturing or shipping 2
No Known Device Problem 2
Dislodged or dislocated 1
Detachment of device or device component 1
Detachment of device component 1
Design/structure problem 1
Foreign material 1
Device abrasion from instrument or another object 1
Device, or device fragments remain in patient 1
Sticking 1
Fitting problem 1
Total Device Problems 24

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 1 0
Class II 1 0 0 2 3 8 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Feb-24-2012
2 Cardinal Health II Jan-27-2012
3 Cardinal Health II Jan-26-2012
4 Cardinal Health II Nov-07-2011
5 Cardinal Health II Oct-31-2011
6 Cardinal Health II Mar-16-2011
7 Custom Medical Specialties, Inc. I Sep-20-2012
8 Customed, Inc II Mar-21-2012
9 DeRoyal Industries Inc II Jul-13-2012
10 DeRoyal Industries Inc II Mar-11-2010
11 Genzyme Corporation II Aug-28-2010
12 Medline Industries Inc II Dec-19-2012
13 Medline Industries Inc II Dec-17-2012
14 Merit Medical Systems, Inc II Sep-25-2007
15 Merit Medical Systems, Inc. II Dec-03-2012

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