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Suture USP 0

by Suturion AB

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17350154050551 UDI-DI Date15 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / Reference
BOM 1055S rev 05 Suture PDO USP 0 - Sterilized
Primary DI / UDI-DI
17350154050551
510(k) Number
FDA Product Code
NEW
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device Class
Class II
Regulation Number
878.4840
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Suturion AB

Properties

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

Other properties (7)

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