Duns Number:243385601
Device Description: the ice o therm pro is used for applying controlled localized contrast ( hot and cold ) to the ice o therm pro is used for applying controlled localized contrast ( hot and cold ) to a specific part of the body.
Catalog Number
-
Brand Name
ice o therm pro
Version/Model Number
contrast
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 08, 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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
65fdd34f-f126-4d2f-ace9-b3e3244f0c07
Public Version Date
July 07, 2020
Public Version Number
5
DI Record Publish Date
September 25, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |