Identity
- Trade Name
- CivaDerm FDA UDI
- Generic Name
- Manual brachytherapy system FDA UDI
- Model / Reference
- CivaDerm FDA UDI
Identifiers
- Catalog Number
- P-0296 FDA UDI
- Primary DI / UDI-DI
- 00869497000128 FDA UDI
- 510(k) Number
- K191324 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
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
MR Conditional FDA UDI
Category: Manual brachytherapy system
A comprehensive manual brachytherapy system used for delivering palliative or therapeutic radiation doses to specific anatomical regions. The device is designed with a manually brought together assembly of therapeutic, independent devices that deliver radioactive sources for brachytherapy treatment.
Similar devices
Also classified as Manual brachytherapy system.
- I-125 Seed — Eckert & Ziegler BEBIG GmbH · Class II
- EchoStrand Brachytherapy Kit I-125 — Eckert & Ziegler BEBIG GmbH
- Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, 3pk — Eckert & Ziegler BEBIG GmbH · Class I
- Applicator Brachytherapy Kit — Eckert & Ziegler BEBIG GmbH
- Advantage I-125® — ISOAID, L.L.C. · Class II
- AnchorLoad Brachytherapy Kit — Eckert & Ziegler BEBIG GmbH
- VariLoad Brachytherapy Kit PD-103 — Eckert & Ziegler BEBIG GmbH
- AnchorLoad Brachytherapy Kit - Loose Load — Eckert & Ziegler BEBIG GmbH
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
- CivaTech Oncology Inc.
Sources (1)
- FDA UDI a23deb41-38fc-46f8-b1cd-b3870912b22e 34 fields · synced Jul 26, 2026