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SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192 FDA UDI
- Generic Name
- Remote-afterloading brachytherapy system FDA UDI
- Model / Reference
- 1321-0201 FDA UDI
Identifiers
- Catalog Number
- 1321-0201 FDA UDI
- Primary DI / UDI-DI
- 04049223114961 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Remote-afterloading brachytherapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192 by Eckert & Ziegler BEBIG GmbH — Class II — FDA UDI — listed in FDA GUDID
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 II | Pending data |
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Manufacturer
- Manufacturer
- Eckert & Ziegler BEBIG GmbH
Sources (1)
- FDA UDI f548a226-0f60-46b3-b95e-07b1d0734e94 35 fields · synced Jun 1, 2026