Identity
- Trade Name
- SIR-Spheres Accessories Pack FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder) FDA UDI
- Model / Reference
- SIR-K002 FDA UDI
- Description
- Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850014612092 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose brachytherapy system applicator, manual
SIR-Spheres Accessories Pack by Sirtex Medical Pty Ltd — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sirtex Medical Pty Ltd
Sources (1)
- FDA UDI 64326aba-fe54-45ed-8dc1-9286d6cad377 34 fields · synced Jun 8, 2026