Identity
- Trade Name
- TheraMark™ FDA UDI
- Generic Name
- Manual brachytherapy source, temporary placement FDA UDI
- Device Name
- TheraMark (AgX100 loose seed - 7 cm ) - STERILE FDA UDI
- Model / Reference
- TG447i FDA UDI
- Description
- TheraMark (AgX100 loose seed - 7 cm ) - STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813787022284 FDA UDI
- 510(k) Number
- K111979 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Manual brachytherapy source, temporary placement 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
Category: Manual brachytherapy source, temporary placement
TheraMark™ by Theragenics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Theragenics Corp.
Sources (1)
- FDA UDI d3e317f3-b0df-4c89-b46c-6f190d6d500a 34 fields · synced Jun 1, 2026