Identity
- Trade Name
- CivaString FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Model / Reference
- CivaString FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869497000104 FDA UDI
- 510(k) Number
- K082159 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
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 source, permanent implant
CivaString by CivaTech Oncology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual brachytherapy source, permanent implant.
- OncoSeedTM — MEDI-PHYSICS, INC. · Class II
- TheraSeed — THERAGENICS CORP. · Class II
- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
- I-125 SeedTM Sterile Convenience Pack — MEDI-PHYSICS, INC. · Class II
- TheraSphere Y90 Glass Microspheres 16.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTD · Class III
- Gold Marker — RIVERPOINT MEDICAL LLC · Class II
- Thin SeedTM — MEDI-PHYSICS, INC. · Class II
- OncoSeedTM — MEDI-PHYSICS, INC. · Class II
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
- CivaTech Oncology Inc.
Sources (1)
- FDA UDI c2ffc341-fd54-4184-a18a-0b40078fe840 34 fields · synced Jun 6, 2026