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Halyard 50697

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20680651506973 UDI-DI Date31 Aug 2020ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Isolation gown, single-use
Model / Ref / Catalog
50697
Primary DI / UDI-DI
20680651506973
FDA Product Code
FYC
GMDN Term
Isolation gown, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
In Commercial Distribution

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No