Identity
- Trade Name
- TheraSphere Administration Accessory Kit (US) FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Device Name
- For use with a TheraSphere Administration Set to administer TheraSphere Y90 Glass Microspheres FDA UDI
- Model / Reference
- K125914-001 FDA UDI
- Description
- For use with a TheraSphere Administration Set to administer TheraSphere Y90 Glass Microspheres FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060116922073 FDA UDI
- FDA Product Code
- NAW FDA UDI
- GMDN Term
- Manual brachytherapy source, permanent implant FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
No
FDA UDI
Category: Manual brachytherapy source, permanent implant
TheraSphere Administration Accessory Kit (US) by Biocompatibles Uk Ltd — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Biocompatibles Uk Ltd
Sources (1)
- FDA UDI b92ce664-b432-4b39-9a9e-2cdc543134b9 34 fields · synced Jun 8, 2026