Identity
- Trade Name
- TheraLoad® with TheraSeed® FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Device Name
- TheraLoad with x = 1-20 seeds and 0 or more spacers for CN FDA UDI
- Model / Reference
- XX82x FDA UDI
- Description
- TheraLoad with x = 1-20 seeds and 0 or more spacers for CN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813787020945 FDA UDI
- 510(k) Number
- K043596 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
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
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
Radiation Sterilization FDA UDI
MR Conditional FDA UDI
TheraLoad® with TheraSeed® by Theragenics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K043596 also covers:
- TheraLoad® with I-Seed — THERAGENICS CORP.
- TheraLoad® with TheraSeed® — THERAGENICS CORP.
- TheraSleeve® with I-Seed — THERAGENICS CORP.
- TheraSleeve® with I-Seed — THERAGENICS CORP.
- TheraSleeve® with TheraSeed® — THERAGENICS CORP.
- TheraSleeve® with TheraSeed® — THERAGENICS CORP.
- TheraStrand® with I-Seed — THERAGENICS CORP.
- TheraStrand® with I-Seed — THERAGENICS CORP.
- TheraStrand® with I-Seed — THERAGENICS CORP.
- TheraStrand® with I-Seed — THERAGENICS CORP.
- TheraStrand® with I-Seed — THERAGENICS CORP.
- TheraStrand® with I-Seed — THERAGENICS CORP.
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 d6c8f6f4-81af-4870-8b9a-31c803c80996 35 fields · synced Jun 8, 2026