Duns Number:877266163
Device Description: Cryogen Cooling
Catalog Number
-
Brand Name
CoolTouch
Version/Model Number
7435-0200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 26, 2018
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)
Yes
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
357319f6-85f4-4b29-b7cf-2a35f440e652
Public Version Date
August 06, 2020
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10859932006300
Quantity per Package
24
Contains DI Package
00859932006303
Package Discontinue Date
September 26, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |