Identity
- Trade Name
- BrachySource™ FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Device Name
- BrachySource™ I-125 Implant Seed, Loose, Non-Sterile FDA UDI
- Model / Reference
- PS1251L FDA UDI
- Description
- BrachySource™ I-125 Implant Seed, Loose, Non-Sterile FDA UDI
Identifiers
- Catalog Number
- PS1251L FDA UDI
- Primary DI / UDI-DI
- 00801741078194 FDA UDI
- 510(k) Number
- K093663 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Manual 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
- 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
- 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 1484e7f7-d4b1-4821-8bdb-01d94ec24a76 36 fields · synced Jun 8, 2026