N/A 16-1115

by Biomet Microfixation, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841036032616 UDI-DI	Date28 Aug 2018Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Manual scalpel blade, single-use
Model / Ref / Catalog: 16-1115

Primary DI / UDI-DI: 00841036032616
FDA Product Code: GES
GMDN Term: Manual scalpel blade, single-use

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

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

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

Other properties (8)

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