AccessGUDID - DEVICE: External 25L Dewar (07290015487528)

GUDID

Device Identifier (DI) Information

Brand Name: External 25L Dewar
Version or Model: CSS-2004055
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ICECURE MEDICAL LTD

Primary DI Number: 07290015487528
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514758619 *Terms of Use

Device Description: No description.

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:	No
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?
45738	General cryosurgical system, cryogen gas, electronic	An assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 70 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 500 and 1000 millibar

Clinically Relevant Size

[?]

Size Type Text
Depth: 736 Millimeter
Height: 1184 Millimeter
Width: 480 Millimeter

Device Record Status

Public Device Record Key: 1b2f17bb-b73f-4660-9097-b62cd6d5d1ee
Public Version Date: May 13, 2025
Public Version Number: 1
DI Record Publish Date: May 05, 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
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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