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Bionix Radiation Therapy Sbrt-4500

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08177400245002 UDI-DIDate27 Oct 2016ListedStatusListed 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  • Withdrawn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
Radiation therapy treatment planning positioning kit
Model / Ref / Catalog
SBRT-4500
Primary DI / UDI-DI
08177400245002
510(k) Number
FDA Product Code
IYE
GMDN Term
Radiation therapy treatment planning positioning kit
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
Not in Commercial Distribution

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: 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
  • Manufacturing Date: No