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Halyard 98701

by Avanos Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number10680651987010 UDI-DI Date6 Jul 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
General surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
98701, 98701-03
Primary DI / UDI-DI
10680651987010
510(k) Number
FDA Product Code
KGC
GMDN Term
General surgical procedure kit, non-medicated, single-use
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: General surgical procedure kit, non-medicated, single-use

Cleared under the same submission (K093312)

Show all (11)

Other devices from Avanos Medical, Inc.

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • 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