Identity
- Trade Name
- selectSeed™ I-125 FDA UDI
- Generic Name
- Remote-afterloading brachytherapy source FDA UDI
- Device Name
- Non-sterile IODINE—125 source for use with seedSelectron® for system verification. Not for human use. Quantity in package is customer order specific in range 1 – 100 seeds. FDA UDI
- Model / Reference
- 130002N-01 FDA UDI
- Description
- Non-sterile IODINE—125 source for use with seedSelectron® for system verification. Not for human use. Quantity in package is customer order specific in range 1 – 100 seeds. FDA UDI
Identifiers
- Catalog Number
- 130002N FDA UDI
- Primary DI / UDI-DI
- 98717213037840 FDA UDI
- 510(k) Number
- K002429 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Remote-afterloading brachytherapy source FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5730 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
selectSeed™ I-125 by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Nucletron B.V.
Sources (1)
- FDA UDI 454fca84-53c2-4c1a-9101-f3198c8c70d7 38 fields · synced May 30, 2026