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Stradis Medical, LLC.

FDA UDI

Class II (US FDA UDI)

by Stradis Medical, Llc

Identity

Trade Name
Stradis Medical, LLC. FDA UDI
Generic Name
Intracardiac circulatory assist axial-pump catheter FDA UDI
Device Name
LVAD TRAY ( LEFT VENTRICULAR ASSIST DEVICE TRAY) FDA UDI
Model / Reference
TMBRF-594 FDA UDI
Description
LVAD TRAY ( LEFT VENTRICULAR ASSIST DEVICE TRAY) FDA UDI

Identifiers

Primary DI / UDI-DI
M752TMBRF5940 FDA UDI
FDA Product Code
OEZ FDA UDI
GMDN Term
Intracardiac circulatory assist axial-pump catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Commercial Distribution
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

Yes

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

Category: Intracardiac circulatory assist axial-pump catheter

Stradis Medical, LLC. by Stradis Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracardiac circulatory assist axial-pump catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stradis Medical, Llc

Sources (1)

  • FDA UDI 33baea94-4de2-45b3-815e-bf78467041d7 34 fields · synced Jun 1, 2026