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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device media, electroconductive
Regulation Description Electroconductive media.
Product CodeGYB
Regulation Number 882.1275
Device Class 2


Premarket Reviews
ManufacturerDecision
CAROL COLE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
SPES MEDICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 3
Appropriate Term/Code Not Available 2
Use of Device Problem 2
Patient Device Interaction Problem 1
Device Operates Differently Than Expected 1
Adhesive 1
Failure to Conduct 1
Electrical /Electronic Property Problem 1
Total Device Problems 12

Recalls
Manufacturer Recall Class Date Posted
1 Pharmaceutical Innovations, Inc. II Jul-12-2019

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