Halyard 43007

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	Number20680651430070 UDI-DI	Date31 Aug 2020Listed	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Withdrawn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: Isolation gown, single-use
Model / Ref / Catalog: 43007

Primary DI / UDI-DI: 20680651430070
FDA Product Code: OEA
GMDN Term: Isolation gown, single-use

Device Class: Class I
Regulation Number: 878.4040
GUDID distribution status: In Commercial Distribution

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See all devices from O&M Halyard Inc. →

Properties

Single Use
Premarket Exempt
Lot / Batch Number

Other properties (11)

Sterile: 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