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Bite Block Of-Z5

by PENTAX Medical Corporation

Ref 04580826926204Model See UDI-DI information for model names

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

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
United StatesGUDID listing GUDID Number04580826926204 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number458082692010506LD Basic UDI-DI 04580826926204UDI-DIDate5 Aug 2026RegisteredStatusActive

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

3 recalls · FDA

    • Terminated Z-2071-2016 FDA Class II initiated 6 Apr 2016

    Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

    • Terminated Z-2290-2014 FDA Class II initiated 17 Jul 2014 on shared 510(k) K850020

    The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

    • Terminated Z-0084-2014 FDA Class I initiated 16 Sep 2013 on shared 510(k) K850020

    PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
Bite Block Of-Z5 EUDAMED
PENTAX Medical GUDID
Generic Name
Endoscopic bite block, basic, reusable
Device Name
Bite Block
Model / Reference
See UDI-DI information for model names EUDAMED
04580826926204 EUDAMED
OF-Z5 GUDID
Primary DI / UDI-DI
04580826926204
Basic UDI-DI
458082692010506LD
Direct Marketing DI
04580826926204
510(k) Number
FDA Product Code
FDS
EMDN Code
G030804 Gastrointestinal endoscopy and echoendoscopy, bite blocks
GMDN Term
Endoscopic bite block, basic, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
See UDI-DI information for model names
04580826926204
GUDID
OF-Z5
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000005227
Authorised representative
PENTAX Europe GmbH DE-AR-000000006

Other devices from PENTAX Medical Corporation

See all devices from PENTAX Medical Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No