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BIONIX RADIATION THERAPY AR-2-35x80

by Bionix Radiation Therapy, LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00817740020973 UDI-DI Date25 Apr 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bionix Radiation Therapy
Generic Name
Anorectal brachytherapy system applicator, remote-afterloading
Model / Ref / Catalog
AR-2-35x80
Primary DI / UDI-DI
00817740020973
FDA Product Code
JAQ
GMDN Term
Anorectal brachytherapy system applicator, remote-afterloading
Device Class
Class II
Regulation Number
892.5700
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Length — 80 Millimeter
Outer Diameter — 35 Millimeter

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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