AccessGUDID - DEVICE: Cryoprobe (07290015487542)

GUDID

Device Identifier (DI) Information

Brand Name: Cryoprobe
Version or Model: CP-2004059
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ICECURE MEDICAL LTD

Primary DI Number: 07290015487542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514758619 *Terms of Use

Device Description: 90-degree handle

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEH	Unit, Cryosurgical, Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240892	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 10 Gauge
Shaft Length: 140 Millimeter

Device Record Status

Public Device Record Key: 020842d7-db20-47a7-9be1-6d79e53f7104
Public Version Date: May 14, 2025
Public Version Number: 1
DI Record Publish Date: May 06, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
17290015487549	5	07290015487542		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18889025716
Email: icecuresupport@icecure-medical.com

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