Duns Number:081840873
Device Description: THERATHERM MOIST HEAT 7X15 SM
Catalog Number
-
Brand Name
CHATTANOOGA
Version/Model Number
1030
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)
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
91159a0a-e848-4b9e-b941-ef9ce1757a02
Public Version Date
May 26, 2022
Public Version Number
3
DI Record Publish Date
September 12, 2016
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 | 784 |
2 | A medical device with a moderate to high risk that requires special controls. | 1030 |
3 | A medical device with high risk that requires premarket approval | 8 |