Identity
- Trade Name
- GammaBeam FDA UDI
- Generic Name
- Teletherapy radionuclide system, conventional FDA UDI
- Device Name
- A Cobalt Teletherapy device by which gamma radiation is delivered for the treatment of cancer FDA UDI
- Model / Reference
- 500 FDA UDI
- Description
- A Cobalt Teletherapy device by which gamma radiation is delivered for the treatment of cancer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540146000074 FDA UDI
- 510(k) Number
- K150191 FDA UDI
- FDA Product Code
- IWB FDA UDI
- GMDN Term
- Teletherapy radionuclide system, conventional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Teletherapy radionuclide system, conventional
GammaBeam by Best Theratronics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Best Theratronics Limited
Sources (1)
- FDA UDI b5c46106-94d9-4f6f-945e-9ddbd5336969 35 fields · synced Jun 6, 2026