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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, surgical, nonabsorbable, expanded, polytetraflouroethylene
Product CodeNBY
Regulation Number 878.5035
Device Class 2


Premarket Reviews
ManufacturerDecision
ANTARMA LLC DBA GOLNIT SUTURES
  SUBSTANTIALLY EQUIVALENT 1
DURASTAT LLC
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PURGO BIOLOGICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 4 4
2023 5 5
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 10
Adverse Event Without Identified Device or Use Problem 3 3
Unsealed Device Packaging 1 1
Dull, Blunt 1 1
Device Contamination with Chemical or Other Material 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Swelling/ Edema 2 2
Insufficient Information 1 1
Unspecified Infection 1 1
Skin Inflammation/ Irritation 1 1

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