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TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial)
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial) FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Device Name
- TheraSphere Yttrium-90 Glass Microspheres 11.5 GBq Dose (US Commercial) FDA UDI
- Model / Reference
- OTT-SPE-FP-700 (990700.SPE) FDA UDI
- Description
- TheraSphere Yttrium-90 Glass Microspheres 11.5 GBq Dose (US Commercial) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060116921540 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual brachytherapy source, permanent implant
TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial) 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 ae27c0e0-89bd-4f1c-8f2b-aaad207ea5e5 34 fields · synced May 30, 2026