Identity
- Trade Name
- I125 Calibration Seed FDA UDI
- Generic Name
- Manual brachytherapy system FDA UDI
- Model / Reference
- I125 Calibration Seed FDA UDI
Identifiers
- Catalog Number
- I125SEEDCAL FDA UDI
- Primary DI / UDI-DI
- 00815165020202 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Manual brachytherapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5730 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual brachytherapy system
I125 Calibration Seed by Eckert & Ziegler BEBIG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual brachytherapy system.
- CivaDerm — CivaTech Oncology Inc. · Class II
- Advantage I-125® — ISOAID, L.L.C. · Class II
- BMT Cleaning Brush Set, Vertical Lock — CONCURE ONCOLOGY, INC. · Class I
- BMT Template Grid, Vertical Lock, Large — CONCURE ONCOLOGY, INC. · Class I
- Advantage I-125® — ISOAID, L.L.C. · Class II
- BMT Fiducial Needle, Round — CONCURE ONCOLOGY, INC. · Class I
- BMT Template Grid Armature & Table Clamp — CONCURE ONCOLOGY, INC. · Class I
- BMT Fiducial Needle, Sharp — CONCURE ONCOLOGY, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eckert & Ziegler BEBIG GmbH
Sources (1)
- FDA UDI b4e8cc22-a6bc-4f69-b1ce-eabc5b091dab 34 fields · synced Jun 6, 2026