Cryoprobe

Basic Information

• Brand Name: Cryoprobe
• Primary DI: 07290015487535
• Version / Model: CP-2004058
• Company Name: ICECURE MEDICAL LTD
• Labeler DUNS: 514758619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-06
• Public Version: 1
• Public Version Date: 2025-05-14
• Public Version Status: New
• Public Device Record Key: 34fe3276-d224-4f6d-bd3d-223fff530450

Device Description

straight handle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	878.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60508	Hand-held cryosurgical system handpiece tip	A sterile component of a hand-held cryosurgery system intended to be attached to the system handpiece to deliver liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin/subcutaneous tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It is typically a closed-end needle intended to deliver focused cooling to the therapy site without destroying healthy tissues. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290015487535	GS1
Package	17290015487532	GS1	Box	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240892	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	10	Gauge
Stent Length	140	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -22 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 25 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 500 – 1000 millibar
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 60 Percent (%) Relative Humidity