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Prosense™ System 100-127 Vac

FDA UDI

Class II (US FDA UDI)

by Icecure Medical Ltd

Identity

Trade Name
PROSENSE™ SYSTEM 100-127 VAC FDA UDI
Generic Name
General cryosurgical system, cryogen gas, electronic FDA UDI
Model / Reference
FAS3000000 FDA UDI

Identifiers

Catalog Number
FAS3000000 FDA UDI
Primary DI / UDI-DI
07290015487160 FDA UDI
510(k) Number
K183213 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

Dimensions & Sizes

Size
Weight — 150 Kilogram FDA UDI
Depth — 27.56 Inch FDA UDI
Width — 19.68 Inch FDA UDI
Height — 47.24 Inch FDA UDI

Category: General cryosurgical system, cryogen gas, electronic

Prosense™ System 100-127 Vac by Icecure Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K183213 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icecure Medical Ltd

Sources (1)

  • FDA UDI 0c731b7b-9a69-4cff-86cb-643db32d2f1d 37 fields · synced May 30, 2026