N/A 70029

by Galemed 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04710810084157 UDI-DI	Date4 Mar 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: General surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog: 70029, AB0328

Primary DI / UDI-DI: 04710810084157
FDA Product Code: BYH
GMDN Term: General surgical procedure kit, non-medicated, single-use

Device Class: Class I
Regulation Number: 868.5995
GUDID distribution status: In Commercial Distribution

Other devices from Galemed Corp.

N/A 5428

Class II
N/A 5429

Class II
N/A AM0002

Class II
N/A AM0001

Class II
N/A AM0003

Class II
N/A 78013

Class I

See all devices from Galemed Corp. →

Properties

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

Other properties (8)

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