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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device lubricant, patient
Regulation Description Patient lubricant.
Product CodeKMJ
Regulation Number 880.6375
Device Class 1


Premarket Reviews
ManufacturerDecision
PEDIATRIC PHARMACEUTICALS INC.
  SUBSTANTIALLY EQUIVALENT 1
SION BIOTEXT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 1
Use of Device Problem 1
Device Contamination with Chemical or Other Material 1
Total Device Problems 3

Recalls
Manufacturer Recall Class Date Posted
1 Amerx Health Care Corp. II Jul-20-2016
2 MEDLINE IND II Jan-10-2017

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