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TheraSphere Administration Set
FDA UDIEUDAMEDClass III (US FDA UDI)
Ref OTT-SPE-FP-226Model TheraSphere Administration Set (CEA); Single
Identity
- Trade Name
- TheraSphere Administration Set FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Device Name
- TheraSphere Administration Set (CEA) EUDAMEDAdministration Set to be used for infusion of TheraSphere Y90 Glass Microspheres FDA UDI
- Model / Reference
- TheraSphere Administration Set (CEA); Single EUDAMEDOTT-SPE-FP-226 EUDAMED990226.SPE FDA UDI
- Description
- Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060116920253 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060116920253 EUDAMED
- FDA Product Code
- NAW FDA UDI
- EMDN Code
- J0502 BRACHYTHERAPY ADMINISTRATION KITS EUDAMED
- GMDN Term
- Manual brachytherapy source, permanent implant FDA UDI
Classification
- Device Class
- Class AIMDD EUDAMEDClass III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 Administration Set by Biocompatibles Uk Ltd — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Biocompatibles Uk Ltd
Sources (2)
- FDA UDI 0a306c99-a555-4748-af3b-ac772004df36 34 fields · synced Jul 9, 2026
- EUDAMED 981631d3-2a48-49f7-a9cf-de6d1c01b4f1 61 fields · synced Jul 9, 2026