BrachySource™, SourceLink™

FDA UDI

Class II (US FDA UDI)

by Bard Brachytherapy, Inc

Identity

Trade Name: BrachySource™, SourceLink™ FDA UDI
Generic Name: Brachytherapy source spacer FDA UDI
Device Name: BrachySource™ I-125 Implant Seed, Loose, Non-Sterile, with pack of SourceLink™ Connectors FDA UDI
Model / Reference: 1251LINKL FDA UDI
Description: BrachySource™ I-125 Implant Seed, Loose, Non-Sterile, with pack of SourceLink™ Connectors FDA UDI

Identifiers

Catalog Number: 1251LINKL FDA UDI
Primary DI / UDI-DI: 00801741078316 FDA UDI
510(k) Number: K093663 FDA UDI
FDA Product Code: KXK FDA UDI
GMDN Term: Brachytherapy source spacer 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Manual brachytherapy source, permanent implant Brachytherapy source spacer

BrachySource™, SourceLink™ by Bard Brachytherapy, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 ce9fcb5a-a74a-4cc7-8675-9fb5bcf65ff6 37 fields · synced Jun 8, 2026