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TYSHAK NuCLEUS™

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
TYSHAK NuCLEUS™ FDA UDI
Generic Name
Cardiac valvuloplasty catheter FDA UDI
Device Name
TN030 TYSHAK NUCLEUS 18X3X100 FDA UDI
Model / Reference
612091 FDA UDI
Description
TN030 TYSHAK NUCLEUS 18X3X100 FDA UDI

Identifiers

Catalog Number
612091 FDA UDI
Primary DI / UDI-DI
04046964511882 FDA UDI
510(k) Number
K121859 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

TYSHAK NuCLEUS™ by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121859 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B Braun Interventional Systems, Inc

Sources (1)

  • FDA UDI e1d08649-91a8-4125-945e-136e3ce4511e 38 fields · synced Jun 6, 2026