Skip to content

Vaginal Applicator Set with CT Cylinders GM11004140

by Varian Medical Systems Deutschland GmbH

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 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 Number00816389022997 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-3055-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011

    Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.

    • Terminated Z-0282-2012 FDA Unclassified (pre-2012) initiated 20 May 2010

    The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Vaginal Applicator Set with CT Cylinders
Generic Name
Tongue brachytherapy system applicator, remote-afterloading
Model / Reference
GM11004140
Primary DI / UDI-DI
00816389022997
510(k) Number
FDA Product Code
JAQ
GMDN Term
Tongue brachytherapy system applicator, remote-afterloading
Device Class
Class II
Regulation Number
892.5700
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K033371)

Show all (12)

Other devices from Varian Medical Systems Deutschland GmbH

See all devices from Varian Medical Systems Deutschland GmbH →

Properties

  • Convenience Kit
  • Lot / Batch Number

Other properties (12)

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