Identity
- Trade Name
- TheraSeed FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Device Name
- Loose seeds in a vial for 3rd party processing FDA UDI
- Model / Reference
- XX400 FDA UDI
- Description
- Loose seeds in a vial for 3rd party processing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813787020518 FDA UDI
- 510(k) Number
- K010283 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
No
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
MR Conditional FDA UDI
Category: Manual brachytherapy source, permanent implant
TheraSeed by Theragenics Corp. — 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® — 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
- BrachySource™ — BARD BRACHYTHERAPY, INC · Class II
Cleared under the same submission
K010283 also covers:
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed® — BARD BRACHYTHERAPY, INC
- TheraSeed — THERAGENICS CORP.
- TheraSeed — THERAGENICS CORP.
- TheraSeed — THERAGENICS CORP.
- TheraSeed — THERAGENICS CORP.
- TheraSeed — THERAGENICS CORP.
- TheraSeed — THERAGENICS CORP.
- TheraSeed — THERAGENICS CORP.
- TheraSeed — 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 4c548105-e217-46c7-a725-94ea8e000900 34 fields · synced Jun 8, 2026