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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gauze/sponge, internal
Product CodeEFQ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
A PLUS INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ALBA HEALTH
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 6
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 3
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
DYNAREX
  SUBSTANTIALLY EQUIVALENT 4
INVOTEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  SUBSTANTIALLY EQUIVALENT 5
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEROCEL
  SUBSTANTIALLY EQUIVALENT 1
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Material frayed 7
Material fragmentation 3
Device expiration issue 2
Break 1
Device, or device fragments remain in patient 1
Other (for use when an appropriate device code cannot be identified) 1
Detachment of device or device component 1
No Known Device Problem 1
Total Device Problems 17

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