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Cover plate II without cylinder hole, with fixation screws GM11007020

by Varian Medical Systems Deutschland GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

17 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816389023956 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

17 recalls · FDA

    • Terminated Z-0607-2013 FDA Class II initiated 28 Sep 2012

    The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.

  • 6 recalls, same reason

    • Terminated Z-2997-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011
    • Terminated Z-2995-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011
    • Terminated Z-2998-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011
    • Terminated Z-2999-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011
    • Terminated Z-3000-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011
    • Terminated Z-2996-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011

    Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.

    • Terminated Z-3013-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011

    Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.

  • 3 recalls, same reason

    • Terminated Z-2993-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011
    • Terminated Z-2991-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011
    • Terminated Z-2992-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011

    Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.

  • 3 recalls, same reason

    • Terminated Z-0327-2012 FDA Unclassified (pre-2012) initiated 30 Sep 2008
    • Terminated Z-0326-2012 FDA Unclassified (pre-2012) initiated 30 Sep 2008
    • Terminated Z-0328-2012 FDA Unclassified (pre-2012) initiated 30 Sep 2008

    Plastic needle tip could possibly crack or separate.

    • Terminated Z-0295-2012 FDA Unclassified (pre-2012) initiated 5 Aug 2008

    GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.

    • Terminated Z-1268-06 FDA Unclassified (pre-2012) initiated 1 May 2006

    Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.

    • Terminated Z-0921-05 FDA Unclassified (pre-2012) initiated 14 Apr 2005

    A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Cover plate II without cylinder hole, with fixation screws
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading
Model / Ref / Catalog
GM11007020
Primary DI / UDI-DI
00816389023956
510(k) Number
FDA Product Code
JAQ
GMDN Term
General-purpose brachytherapy system applicator, remote-afterloading
Device Class
Class II
Regulation Number
892.5700
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: General-purpose brachytherapy system applicator, remote-afterloading

Cleared under the same submission (K983436)

Show all (12)

Other devices from Varian Medical Systems Deutschland GmbH

See all devices from Varian Medical Systems Deutschland GmbH →

Properties

  • Lot / Batch Number

Other properties (13)

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