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Halyard 29272

by O&M Halyard Inc.

Ref 29272

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 Number06806517EC0027D Basic UDI-DI 10680651292725UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10680651292725 UDI-DI Date4 Dec 2015ListedStatusListed 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  • Withdrawn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
Instrument/equipment drape, single-use, sterile
Device Name
Equipment covers Sterile
Model / Reference
29272
Description
PADDED HEAVY DUTY BACK TABLE COVER, FAN FOLD, 80IN X 110IN / 203 CM X 279 CM
Primary DI / UDI-DI
10680651292725
Basic UDI-DI
06806517EC0027D
510(k) Number
FDA Product Code
KKX
EMDN Code
T030199 Covers, instruments and equipment - other
GMDN Term
Instrument/equipment drape, single-use, sterile
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: Instrument/equipment drape, single-use, sterile

Cleared under the same submission (K083234)

Show all (12)

Other devices from O&M Halyard Inc.

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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