Duns Number:831996595
Device Description: Description: 1,1,1,2 Tetrafluoroethane;Cylinder: PD;Valve: CGA 600;For reduction of pain Description: 1,1,1,2 Tetrafluoroethane;Cylinder: PD;Valve: CGA 600;For reduction of pain and to prevent any undesired skin damage by cooling of skin prior to treatment with a Candela laser system. Refer to the laser manufacturer's instructions for installation and use of the cryogen.
Catalog Number
RL MDGPD12CA44
Brand Name
SkinKool
Version/Model Number
Cryogenic Gas
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
c3bd1862-5a6f-44fc-b294-6f48ba7c0d71
Public Version Date
July 13, 2021
Public Version Number
1
DI Record Publish Date
July 05, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 281 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |