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SilverHawk

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
SilverHawk FDA UDI
Generic Name
Mechanical atherectomy system catheter, peripheral FDA UDI
Device Name
Cutter Driver for Plaque Excision Systems FDA UDI
Model / Reference
FG02550 FDA UDI
Description
Cutter Driver for Plaque Excision Systems FDA UDI

Identifiers

Primary DI / UDI-DI
00821684043318 FDA UDI
FDA Product Code
MCW FDA UDI
GMDN Term
Mechanical atherectomy system catheter, peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4875 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

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: Mechanical atherectomy system catheter, peripheral

SilverHawk by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system catheter, peripheral.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 67132aa5-ed06-440e-8512-28d4b8264bba 35 fields · synced May 31, 2026