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Optilene G3090041

by B Braun Surgical SA

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04046964240164 UDI-DI Date23 Aug 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Optilene
Generic Name
Polyolefin/fluoropolymer suture, monofilament
Model / Ref / Catalog
G3090041
Description
OPTILENE 3/0 (2) 75CM HR26 CV RCP
Primary DI / UDI-DI
04046964240164
FDA Product Code
GAW
GMDN Term
Polyolefin/fluoropolymer suture, monofilament
Device Class
Class II
Regulation Number
878.5010
GUDID distribution status
Not in Commercial Distribution
Size
Length — 75.00 Centimeter

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No