Orthopaedic Surgical Instruments Graduated drill bit, ø4x350mm (sterile)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08059386747957 UDI-DI	Date27 Oct 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Orthopaedic Surgical Instruments
Generic Name: Cannulated surgical drill bit, single-use
Model / Ref / Catalog: Graduated drill bit, ø4x350mm (sterile), DT03013A

Primary DI / UDI-DI: 08059386747957
FDA Product Code: HTW
GMDN Term: Cannulated surgical drill bit, single-use

Device Class: Class I
Regulation Number: 888.4540
GUDID distribution status: In Commercial Distribution

Size: Outer Diameter — 4 Millimeter

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Properties

Sterile
Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (7)

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