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SA1608

by GNI Co., Ltd

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 8 Jun 2026. What this means

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800046000567 UDI-DI Date9 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Orthodontic anchoring screw
Model / reference
SA1608
Primary DI / UDI-DI
08800046000567
FDA product code
OAT
GMDN term
Orthodontic anchoring screw
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthodontic anchoring screw

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See all devices from GNI Co., Ltd →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date

Other properties (8)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No