Halyard 89641

by O&M Halyard 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	Number10680651896411 UDI-DI	Date4 Dec 2015Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Halyard
Generic Name: Instrument/equipment drape, single-use, sterile
Model / Reference: 89641

Primary DI / UDI-DI: 10680651896411
FDA Product Code: KKX
GMDN Term: Instrument/equipment drape, single-use, sterile

Device Class: Class II
Regulation Number: 878.4370
GUDID distribution status: In Commercial Distribution

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Properties

Sterile
Single Use
Lot / Batch Number
Expiration Date

Other properties (10)

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