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Halyard 88411

by O&M Halyard Inc.

Ref 88411

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number06806517SP010SDP Basic UDI-DI 10680651884111UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10680651884111 UDI-DI Date15 Apr 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2520-2025 FDA Class II initiated 17 Jul 2025

    Surgical drape packs may have open seals, which may compromise the sterility of the product.

    • Ongoing Z-0983-2025 FDA Class II initiated 26 Nov 2024

    Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Halyard
Generic Name
General surgical procedure kit, non-medicated, single-use
Device Name
Surgical Packs Sterile
Model / Reference
88411
Primary DI / UDI-DI
10680651884111
Basic UDI-DI
06806517SP010SDP
510(k) Number
FDA Product Code
KKX
EMDN Code
T020199 Surgical drapes - other
GMDN Term
General surgical procedure kit, non-medicated, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4370
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

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

Cleared under the same submission (K083234)

Show all (12)

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

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

Other properties (20)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: 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