Duns Number:867673159
Device Description: Pressure PreventionRetail Foam Product Description: Comfort Touch Gel Packs 3EA/Box
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
RTL2017CTGP
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
IME
Product Code Name
Pack, hot or cold, reusable
Public Device Record Key
a25774de-54bb-4fad-a2e9-4d527fb6e6d8
Public Version Date
July 01, 2019
Public Version Number
1
DI Record Publish Date
June 21, 2019
Package DI Number
10822383972074
Quantity per Package
36
Contains DI Package
50822383972072
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |