HF12047

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04048266138354 UDI-DI	Date1 Nov 2021Listed	StatusListed GUDID: not in commercial distribution

Official records

AccessGUDID record UDI-DI 04048266138354

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name: Diaphysis prosthesis
Model / reference: HF12047

Primary DI / UDI-DI: 04048266138354
FDA product code: HTO
GMDN term: Diaphysis prosthesis

Device class: Class I
Regulation number: 888.4540
GUDID distribution status: Not in Commercial Distribution

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Properties

Supplied sterile
Implantable
Prescription use
Premarket exempt
Lot / batch number

Other properties (10)

Sterilise before use: No
Single use: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Serial number: No
Expiration date: No
Manufacturing date: No