TheraSphere Administration Set
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- TheraSphere Administration Set FDA UDI
- Generic Name
- Manual-afterloading brachytherapy system source delivery procedure kit FDA UDI
- Device Name
- TheraSphere Administration Set (B Braun) EUDAMEDAdministration Set to be used for infusion of TheraSphere Y90 Glass Microspheres FDA UDI
- Model / Reference
- OTT-SPE-FP-001 EUDAMEDFDA UDITheraSphere Administration Set (B Braun); Box of 20 EUDAMEDTheraSphere Administration Set (B Braun); Single EUDAMED
- Description
- Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060116920635 EUDAMEDFDA UDI05060116920659 EUDAMED
- Basic UDI-DI
- B-05060116920659 EUDAMEDB-05060116920635 EUDAMED
- FDA Product Code
- NAW FDA UDI
- EMDN Code
- J0502 BRACHYTHERAPY ADMINISTRATION KITS EUDAMED
- GMDN Term
- Manual-afterloading brachytherapy system source delivery procedure kit FDA UDI
Classification
- Device Class
- Class AIMDD EUDAMEDClass III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
Yes
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Manual-afterloading brachytherapy system source delivery procedure kit
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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Also classified as Manual-afterloading brachytherapy system source delivery procedure kit.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 (3)
- FDA UDI 7182fc2f-39f0-4238-9d0f-00e43cc6f4e9 34 fields · synced Jun 19, 2026
- EUDAMED a08bf998-46c7-406a-8e87-7e86abdfc747 61 fields · synced Jun 14, 2026
- EUDAMED b391d9dc-747f-4e74-8689-dc450ef044e9 61 fields · synced Jun 19, 2026