Duns Number:430315948
Device Description: Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.
Catalog Number
-
Brand Name
CRYO T-SHOCK 4.0
Version/Model Number
CRYO T-SHOCK 4.0
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IME
Product Code Name
Pack, Hot Or Cold, Reusable
Public Device Record Key
9ceee173-498a-4215-b6ab-283f6fa124ad
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 24, 2022
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 | 2 |