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Halyard 79577

by O&M Halyard Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10680651795776 UDI-DI Date17 Jul 2020ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0257-2013 FDA Class II initiated 5 Jul 2012

    Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Halyard
Generic Name
Surgical gown, single-use
Model / Ref / Catalog
79577
Primary DI / UDI-DI
10680651795776
510(k) Number
FDA Product Code
KKX
GMDN Term
Surgical gown, single-use
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical gown, single-use

Cleared under the same submission (K842115)

Show all (12)

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • 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
  • Expiration Date: No
  • Manufacturing Date: No