Skip to content

Not used 1127

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 found

in data synced 22 Oct 2026

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 Number00816389029965 UDI-DI Date17 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Not used
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading
Model / Reference
1127
Primary DI / UDI-DI
00816389029965
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
Size
Length — 150 Centimeter

Related devices

Cleared under the same submission (K952913)

Show all (12)

Other devices from Varian Medical Systems Deutschland GmbH

See all devices from Varian Medical Systems Deutschland GmbH →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: 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