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Pkit, Sst Bi-Lat Chest Hip Covers, 1/Ea

by Mizuho Orthopedic Systems, Inc.

Ref 6985-1

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Overview

The PKIT SST BI-LAT CHEST HIP COVERS, 1/EA is a medical device designed to provide sterile coverage for operating tables. It is used in various healthcare settings, including emergency departments and operating rooms. The device features a sterile sleeve design, allowing for easy attachment to operating table edges. Its self-testing capabilities enable quick verification of the device's sterility.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0842430158956Y Basic UDI-DI 00842430112386UDI-DIDate2 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00842430112386 UDI-DI Date3 Sep 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Pkit,sst Bi-Lat Chest Hip Covers, 1/Ea EUDAMED
Pkit, Sst Bi-Lat Chest Hip Covers GUDID
Generic Name
Surgical linen/cushion set
Device Name
Operating Table Accessories
Model / Ref / Catalog
6985-1, 6985
Primary DI / UDI-DI
00842430112386
Basic UDI-DI
0842430158956Y
FDA Product Code
KME
EMDN Code
Z12011285 Patient positioning instruments - consumables
GMDN Term
Surgical linen/cushion set
Device Class
Class I
Regulation Number
880.6060
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000002901
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Mizuho Orthopedic Systems, Inc.

See all devices from Mizuho Orthopedic Systems, Inc. →

Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No