ASSI.BRC5XL

by Accurate Surgical & Scientific Instruments Corp.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841645117407 UDI-DI	Date7 Jul 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00841645117407

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Assi
Generic name: Tourniquet cuff, reusable
Model / reference: ASSI.BRC5XL
Description: Breast Reduction Compression Device Extra Large tourniquet, for approx. 1300gm reduction 5/SET STERILE

Primary DI / UDI-DI: 00841645117407
FDA product code: GAX
GMDN term: Tourniquet cuff, reusable

Device class: Class I
Regulation number: 878.5900
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Premarket exempt
Lot / batch number

Other properties (11)

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