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Rotablator™ Rotational Atherectomy System Console Kit

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Rotablator™ Rotational Atherectomy System Console Kit FDA UDI
Generic Name
Mechanical atherectomy system, coronary, line-powered FDA UDI
Device Name
Rotational Atherectomy System FDA UDI
Model / Reference
H802220200391 FDA UDI
Description
Rotational Atherectomy System FDA UDI

Identifiers

Catalog Number
H802220200391 FDA UDI
Primary DI / UDI-DI
08714729353300 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

Yes

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™ Rotational Atherectomy System Console Kit 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

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 38e77216-b954-44e6-b042-2c2dc3602af3 34 fields · synced May 31, 2026