← Back to catalogue

Rotablator™

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Rotablator™ FDA UDI
Generic Name
Mechanical atherectomy system, coronary, line-powered FDA UDI
Device Name
Dynaglide™ Foot Pedal FDA UDI
Model / Reference
H802224360021 FDA UDI
Description
Dynaglide™ Foot Pedal FDA UDI

Identifiers

Primary DI / UDI-DI
08714729353317 FDA UDI
FDA Product Code
MCX FDA UDI
MCW FDA UDI
GMDN Term
Mechanical atherectomy system, coronary, line-powered FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.4875 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mechanical atherectomy system, coronary, line-powered

Rotablator™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system, coronary, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI bc47e070-9c46-4f65-acbb-a811e1077ed8 33 fields · synced Jun 8, 2026