Identity
- Trade Name
- IsoSeed® I-125, unsterile, loose, high activity FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Device Name
- Ophth. seeds, unsterile, loose, high activity FDA UDI
- Model / Reference
- I25.S17PLUS-ULH FDA UDI
- Description
- Ophth. seeds, unsterile, loose, high activity FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049223117184 FDA UDI
- 510(k) Number
- K140849 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Manual brachytherapy source, permanent implant 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
No
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
IsoSeed® I-125, unsterile, loose, high activity by Eckert & Ziegler BEBIG GmbH — 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
- Eckert & Ziegler BEBIG GmbH
Sources (1)
- FDA UDI fc42ddc3-abe5-459b-b014-41e5fdbc42ce 36 fields · synced Jun 1, 2026