Identity
- Trade Name
- BrachySource™ FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- BrachySource™ I-125 Implant Seed in Cartridges FDA UDI
- Model / Reference
- 1251CSRA FDA UDI
- Description
- BrachySource™ I-125 Implant Seed in Cartridges FDA UDI
Identifiers
- Catalog Number
- 1251CSRA FDA UDI
- Primary DI / UDI-DI
- 00801741078279 FDA UDI
- 510(k) Number
- K093663 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: General-purpose brachytherapy system applicator, manualManual brachytherapy source, permanent implant
BrachySource™ by Bard Brachytherapy, 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
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- Gold Marker — RIVERPOINT MEDICAL LLC · Class II
- Thin SeedTM — MEDI-PHYSICS, INC. · Class II
- OncoSeedTM — MEDI-PHYSICS, INC. · Class II
- TheraSeed — THERAGENICS CORP. · Class II
Cleared under the same submission
K093663 also covers:
- BrachySource™ — BARD BRACHYTHERAPY, INC
- BrachySource™ — BARD BRACHYTHERAPY, INC
- BrachySource™ — BARD BRACHYTHERAPY, INC
- BrachySource™ — BARD BRACHYTHERAPY, INC
- BrachySource™ — BARD BRACHYTHERAPY, INC
- BrachySource™ — BARD BRACHYTHERAPY, INC
- BrachySource™ — BARD BRACHYTHERAPY, INC
- BrachySource™ — BARD BRACHYTHERAPY, INC
- BrachySource™, ReadyLink™ — BARD BRACHYTHERAPY, INC
- BrachySource™, SourceLink™ — BARD BRACHYTHERAPY, INC
- BrachySource™, SourceLink™ — BARD BRACHYTHERAPY, INC
- BrachySource™, SourceLink™ — BARD BRACHYTHERAPY, INC
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
- Bard Brachytherapy, Inc
Sources (1)
- FDA UDI 9f1195ac-74d0-4924-8858-22df92b9c722 36 fields · synced May 30, 2026