AccessGUDID - DEVICE: Visica 2 (00868390000211)

GUDID

Device Identifier (DI) Information

Brand Name: Visica 2
Version or Model: VS3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VS3000
Company Name: SANARUS TECHNOLOGIES, INC.

Primary DI Number: 00868390000211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831350785 *Terms of Use

Device Description: The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable probe. The system utilizes a cryogen, liquid nitrogen, as a cooling agent and a resistance heater for thawing. The Visica 2 Console is a self contained, mobile unit featuring an easy to use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allow users to select treatment modes, times, and cycles.

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:	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

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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

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Product Code	Product Code Name
GEH	Unit, Cryosurgical, Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062896	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
Handling Environment Atmospheric Pressure: between 500 and 1013 KiloPascal
Storage Environment Atmospheric Pressure: between 700 and 1013 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 337272b5-a125-4709-929c-8d420781ee29
Public Version Date: April 08, 2022
Public Version Number: 5
DI Record Publish Date: September 06, 2016