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Licox® PMOFC

by GMS, Gesellschaft für medizinische Sondentechnik mbH

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

12 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780041412 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

12 recalls · FDA

    • Terminated Z-0831-2015 FDA Class II initiated 7 Nov 2014

    Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.

  • 9 recalls, same reason

    • Terminated Z-0061-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0056-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0062-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0063-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0060-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0057-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0055-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0054-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0059-2014 FDA Class II initiated 11 Jun 2013

    Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.

    • Terminated Z-0161-2011 FDA Unclassified (pre-2012) initiated 15 Sep 2010

    Incorrect expiration date - The outer boxes of the IP2P Licox Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring Probes, Lot 250210A are labeled with an incorrect shelf life date (10 months too long).

    • Terminated Z-1422-2010 FDA Unclassified (pre-2012) initiated 18 Feb 2010

    One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Licox®
Generic Name
Transistor tester
Model / Ref / Catalog
PMOFC
Primary DI / UDI-DI
10381780041412
FDA Product Code
GWM
GMDN Term
Transistor tester
Device Class
Class II
Regulation Number
882.1620
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K040235)

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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