AccessGUDID - DEVICE: Temperature Sensor (07290015487061)

GUDID

Device Identifier (DI) Information

Brand Name: Temperature Sensor
Version or Model: FAT8000000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FAT8000000
Company Name: ICECURE MEDICAL LTD

Primary DI Number: 07290015487061
Issuing Agency: GS1
Commercial Distribution End Date: June 07, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 514758619 *Terms of Use

Device Description: Temperature Sensor - Use only with IceCure Cryogenic device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
65125	Cryosurgical system temperature probe	A hand-held device intended to be used to monitor tissue temperature during a cryosurgical procedure, typically to measure the temperature in tissue adjacent to the ablated zone to assess extent of ablation and to limit ablation to protect local tissues. It is in the form of a needle-like probe with a temperature sensor and proximal handle with a cable for connecting to the cryosurgical system control unit. 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 [?]
K183213	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Shaft Length: 170 Millimeter
Needle Gauge: 14 Gauge

Device Record Status

Public Device Record Key: de06aee0-9470-45c1-a6b3-dcd894607a4f
Public Version Date: June 15, 2022
Public Version Number: 1
DI Record Publish Date: June 07, 2022