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ICEfx Cryoablation System

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
ICEfx Cryoablation System FDA UDI
Generic Name
General cryosurgical system, cryogen gas, electronic FDA UDI
Device Name
Cryoablation System FDA UDI
Model / Reference
FPRCH8000-02 FDA UDI
Description
Cryoablation System FDA UDI

Identifiers

Catalog Number
FPRCH8000-02 FDA UDI
Primary DI / UDI-DI
00859019006417 FDA UDI
FDA Product Code
GEH FDA UDI
GMDN Term
General cryosurgical system, cryogen gas, electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4350 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
MRI Safety
MR Unsafe FDA UDI

Category: General cryosurgical system, cryogen gas, electronic

ICEfx Cryoablation System by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General cryosurgical system, cryogen gas, electronic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 0f931419-ede7-4ff1-982b-95aea03cc389 36 fields · synced May 30, 2026