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Cryoprobe

FDA UDI

Class II (US FDA UDI)

by Icecure Medical Ltd

Identity

Trade Name
Cryoprobe FDA UDI
Generic Name
Hand-held cryosurgical system handpiece tip FDA UDI
Device Name
straight handle FDA UDI
Model / Reference
CP-2004058 FDA UDI
Description
straight handle FDA UDI

Identifiers

Primary DI / UDI-DI
07290015487535 FDA UDI
510(k) Number
K240892 FDA UDI
FDA Product Code
GEH FDA UDI
GMDN Term
Hand-held cryosurgical system handpiece tip 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

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 10 Gauge FDA UDI
Stent Length — 140 Millimeter FDA UDI

Category: Hand-held cryosurgical system handpiece tip

Cryoprobe by Icecure Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held cryosurgical system handpiece tip.

Cleared under the same submission

K240892 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 34fe3276-d224-4f6d-bd3d-223fff530450 37 fields · synced May 31, 2026