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Equalizer™

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Equalizer™ FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Device Name
Occlusion Balloon Catheter FDA UDI
Model / Reference
M001171100 FDA UDI
Description
Occlusion Balloon Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
08714729402404 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 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

Yes

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

Category: Intravascular occluding balloon catheter, image-guided

Equalizer™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular occluding balloon catheter, image-guided.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 2d7ed6cb-225c-44dc-b14e-c32757ff92bb 34 fields · synced May 31, 2026