B61201

by Black & Black Surgical Inc.

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 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00840329806347 UDI-DI	Date21 Sep 2022Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name: Hand-held surgical retractor, reusable
Model / Ref / Catalog: B61201

Primary DI / UDI-DI: 00840329806347
FDA product code: GAD
GMDN term: Hand-held surgical retractor, reusable

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Premarket exempt
Lot / batch number

Other properties (11)

Supplied sterile: No
Single use: No
Implantable: 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