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Halyard SGCB55-04_0001

by Avid Medical, 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 Number10809160515402 UDI-DI Date9 Mar 2026ListedStatusListed 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  • Withdrawn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
Cardiothoracic surgical procedure kit, medicated, single-use
Model / Ref / Catalog
SGCB55-04_0001, SGCB55-04
Primary DI / UDI-DI
10809160515402
FDA Product Code
OEZ
GMDN Term
Cardiothoracic surgical procedure kit, medicated, single-use
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
In Commercial Distribution

Other devices from Avid Medical, Inc.

See all devices from Avid Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (6)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No