AccessGUDID - DEVICE: IcePearl® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® System (07290104831041)

GUDID

Device Identifier (DI) Information

Brand Name: IcePearl® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® System
Version or Model: FPRPR3606
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FPRPR3606
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 07290104831041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template

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:	Yes
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
GEH	Unit, Cryosurgical, 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: Kit including: Cryoablation Needles 2.1 mm Shaft Diameter; Thermal Sensors Shaft Diameter 1.5 mm; Needle Shaft Length 175 mm; Urethral Warming Set

Device Record Status

Public Device Record Key: 7a17c78b-9262-4885-9ac6-5ae6f4455491
Public Version Date: October 25, 2023
Public Version Number: 7
DI Record Publish Date: August 15, 2016