SA-002

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 20 Oct 2026. What this means

Regulatory status

as of registry sync 20 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08800046045810 UDI-DI	Date11 Oct 2023Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 08800046045810

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name: Surgical screwdriver, reusable
Model / reference: SA-002

Primary DI / UDI-DI: 08800046045810
FDA product code: ECT
GMDN term: Surgical screwdriver, reusable

Device class: Class I
Regulation number: 872.4565
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Convenience kit
Lot / batch number
Manufacturing date

Other properties (11)

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