Identity
- Trade Name
- BrachySource™, SourceLink™ FDA UDI
- Generic Name
- Brachytherapy injection needle FDA UDI
- Device Name
- BrachySource™ I-125 Implant Preloaded in Needles with SourceLink™ Connectors FDA UDI
- Model / Reference
- 1251LINK FDA UDI
- Description
- BrachySource™ I-125 Implant Preloaded in Needles with SourceLink™ Connectors FDA UDI
Identifiers
- Catalog Number
- 1251LINK FDA UDI
- Primary DI / UDI-DI
- 00801741098598 FDA UDI
- 510(k) Number
- K093663 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Brachytherapy injection needle 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: Brachytherapy injection needleManual brachytherapy source, permanent implantBrachytherapy source spacer
BrachySource™, SourceLink™ by Bard Brachytherapy, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Brachytherapy source spacer.
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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™ — BARD BRACHYTHERAPY, INC
- BrachySource™, ReadyLink™ — 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 a52e4c6b-3d7d-492b-bd4f-5f0fa0cc5f22 37 fields · synced Jun 8, 2026