AccessGUDID - DEVICE: Applied Medical Laser (00819601021853)

GUDID

Device Identifier (DI) Information

Brand Name: Applied Medical Laser
Version or Model: Skin Cooling
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RL MDGPD12C996
Company Name: AIRGAS USA LLC

Primary DI Number: 00819601021853
Issuing Agency: GS1
Commercial Distribution End Date: August 05, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 831996595 *Terms of Use

Device Description: Description: H-134a; Cylinder: PD; Valve: CGA 600; R-134a in a canister for use in a Candela laser system. The gas is used for reduction of pain by cooling of skin prior to treatment with a Candela laser system.

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):	No
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?
16635	Freon gas cartridge	A device in the shape of a small sealed cylinder, containing pressurized Freon gas, intended to be inserted into a parent device where it is perforated so that its gas content can serve a specific function (e.g., a source of power or a refrigerant). The effect of the gas has a direct impact upon the functional use of the parent medical device (e.g., an antishock unit, a tourniquet unit, or a cryo-unit). The cartridge is discarded when it is empty of Freon gas.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 52 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Pressure: 81.9 Pound per Square Inch
Weight: 1000 Gram

Device Record Status

Public Device Record Key: 940e9d40-0bb8-461b-ac5c-7e1576b799a1
Public Version Date: November 28, 2022
Public Version Number: 3
DI Record Publish Date: April 19, 2020