AccessGUDID - DEVICE: MultiPoint 1.5 Thermal Sensor (07290104831164)

GUDID

Device Identifier (DI) Information

Brand Name: MultiPoint 1.5 Thermal Sensor
Version or Model: FPRPR4020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FPRPR4020
Company Name: GALIL MEDICAL LTD

Primary DI Number: 07290104831164
Issuing Agency: GS1
Commercial Distribution End Date: August 14, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 531854560 *Terms of Use

Device Description: 1.5mm Multi-Point Thermal Sensor (MTS)

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?
45140	Cryosurgical set	A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions. A typical set will contain cryo needles, thermal sensors, warmer tubes and catheters, warmer cassette, and tube holders. It is typically used for early stages of prostate cancer or late recurrence of localized prostate cancer after radiotherapy where the prostate is cooled to a temperature of -40Â° Celsius. Warming of the areas where freezing is not required is simultaneously carried out. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEY	System, Ablation, Microwave And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Cool, dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Shaft Length: 175 mm
Device Size Text, specify: Shaft diameter: 1.5mm

Device Record Status

Public Device Record Key: 324df954-792a-45db-af73-0bf79c16ece8
Public Version Date: September 03, 2021
Public Version Number: 3
DI Record Publish Date: August 14, 2020