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TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES

FDA UDI

Class II (US FDA UDI)

by Datascope Corp.

Identity

Trade Name
TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES FDA UDI
Generic Name
Intra-aortic balloon catheter FDA UDI
Device Name
TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES FDA UDI
Model / Reference
0684-00-0608 FDA UDI
Description
TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES FDA UDI

Identifiers

Catalog Number
0684-00-0608 FDA UDI
Primary DI / UDI-DI
10607567111728 FDA UDI
FDA Product Code
DSP FDA UDI
GMDN Term
Intra-aortic balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3535 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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 7.5 French FDA UDI

Category: Intra-aortic balloon catheter

TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intra-aortic balloon catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA UDI a2838bff-0dab-4b53-9f27-549adf964d49 36 fields · synced May 30, 2026