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UNIFY PGA Surgical Sutures S-G518XR13-U

by Applied Dental, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

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 Number00814639025606 UDI-DI Date17 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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
UNIFY PGA Surgical Sutures
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / Reference
S-G518XR13-U
Primary DI / UDI-DI
00814639025606
FDA Product Code
GAM
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device Class
Class II
Regulation Number
878.4493
GUDID distribution status
In Commercial Distribution

Other devices from Applied Dental, Inc.

See all devices from Applied Dental, Inc. →

Properties

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

Other properties (8)

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