Brk-1™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical Cardiovascular Division

Identity

Trade Name: BRK-1™ FDA UDI
Generic Name: Cardiac transseptal needle, single-use FDA UDI
Device Name: Transseptal Needle FDA UDI
Model / Reference: 407201 FDA UDI
Description: Transseptal Needle FDA UDI

Identifiers

Catalog Number: 407201 FDA UDI
Primary DI / UDI-DI: 05414734205160 FDA UDI
FDA Product Code: DRC FDA UDI
GMDN Term: Cardiac transseptal needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1390 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: Outer Diameter — 1.3 Millimeter FDA UDI
Length — 71 Centimeter FDA UDI

Category: Cardiac transseptal needle, single-use

Brk-1™ by St. Jude Medical Cardiovascular Division — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac transseptal needle, single-use.

Transseptal Needle — PPMDM · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Needle Free Transseptal Cannula — PPMDM · Class II
Agilis™ — ST. JUDE MEDICAL, INC. · Class II
Agilis™ — ST. JUDE MEDICAL, INC. · Class II
HeartSpan® — Merit Medical · Class II
Needle Free Transseptal Cannula — PPMDM · Class II
SafeSharp Transseptal Needle — PPMDM · Class II

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: St. Jude Medical Cardiovascular Division

Sources (1)

FDA UDI 36be7d37-a8f4-4877-a37b-a680cca157d7 37 fields · synced May 30, 2026