BrachyStar™

FDA UDI

Class I (US FDA UDI)

by Bard Brachytherapy, Inc

Identity

Trade Name: BrachyStar™ FDA UDI
Generic Name: Brachytherapy injection needle FDA UDI
Device Name: BrachyStar Brachytherapy Applicator Seed Implant Needle with Lubricious Coating and cm Markings, 18g x 20cm Length FDA UDI
Model / Reference: 918201 FDA UDI
Description: BrachyStar Brachytherapy Applicator Seed Implant Needle with Lubricious Coating and cm Markings, 18g x 20cm Length FDA UDI

Identifiers

Catalog Number: 918201 FDA UDI
Primary DI / UDI-DI: 00801741075957 FDA UDI
FDA Product Code: IWJ FDA UDI
GMDN Term: Brachytherapy injection needle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.5650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 18 Gauge FDA UDI

Category: Brachytherapy injection needle

BrachyStar™ by Bard Brachytherapy, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Bard Brachytherapy, Inc

Sources (1)

FDA UDI e529c175-06bc-495b-bd82-cf0dac71f9f8 36 fields · synced May 30, 2026