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PBK10002 Custom Peg Board Kit #2

by Xodus Medical, Inc.

Ref PBK10002

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0787551POSITIONINGKITSLN Basic UDI-DI 00787551039467UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00787551039467 UDI-DI Date8 Dec 2022ListedStatusListed 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  • Withdrawn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

Generic Name
Freestanding patient positioner, single-use
Device Name
Air Assist
Model / Ref / Catalog
PBK10002
Primary DI / UDI-DI
00787551039467
Basic UDI-DI
0787551POSITIONINGKITSLN
FDA Product Code
CCX
EMDN Code
Z12011299 Patient positioning instruments – other
GMDN Term
Freestanding patient positioner, single-use
Device Class
Class I
Regulation Number
868.6820
Medical Purpose
To aid hospital facilities in providing a safe and effective method of management of the patient for pressure ulcers and non-movement for patients in the Trendelenburg position, as well as, patient transfer before and after the surgical procedure.
GUDID distribution status
In Commercial Distribution

Related devices

Category: Freestanding patient positioner, single-use

Other devices from Xodus Medical, Inc.

See all devices from Xodus Medical, Inc. →

Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No
  • Manufacturing Date: No