BrachySource™, SourceCap™

FDA UDI

Class II (US FDA UDI)

by Bard Brachytherapy, Inc

Identity

Trade Name: BrachySource™, SourceCap™ FDA UDI
Generic Name: Manual brachytherapy source, permanent implant FDA UDI
Device Name: BrachySource™ I-125 Implant Seed in Cartridges with SourceCap™ EndCaps FDA UDI
Model / Reference: 1251CSF FDA UDI
Description: BrachySource™ I-125 Implant Seed in Cartridges with SourceCap™ EndCaps FDA UDI

Identifiers

Catalog Number: 1251CSF FDA UDI
Primary DI / UDI-DI: 00801741078248 FDA UDI
510(k) Number: K140856 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

Yes

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

MRI Safety

MR Conditional FDA UDI

Category: General-purpose brachytherapy system applicator, manual Manual brachytherapy source, permanent implant Brachytherapy source spacer

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

Similar devices

Also classified as Brachytherapy source spacer.

Theragenics — THERAGENICS CORP. · Class II
Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, 3pk — Eckert & Ziegler BEBIG GmbH · Class I
Theragenics — THERAGENICS CORP. · Class II
Best Medical International — Best Medical International, Inc. · Class II
Best Medical International — Best Medical International, Inc. · Class II
Theragenics — THERAGENICS CORP. · Class II
Spacer 1cm Synthetic 30 piece — Eckert & Ziegler BEBIG GmbH · Class II
SPACER — RIVERPOINT MEDICAL LLC · Class II

Cleared under the same submission

K140856 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bard Brachytherapy, Inc

Sources (1)

FDA UDI 159c238d-6746-4c3a-b0c3-0f55395aece2 37 fields · synced May 30, 2026