Duns Number:867673159
Device Description: Pressure PreventionRetail Foam Product Description: 16" invalid ring,1/pr
Catalog Number
-
Brand Name
Drive
Version/Model Number
8085-MED
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 10, 2017
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
KIC
Product Code Name
CUSHION, FLOTATION
Public Device Record Key
42ecda41-6972-4214-912f-1e3c036397bc
Public Version Date
June 02, 2020
Public Version Number
4
DI Record Publish Date
July 10, 2017
Package DI Number
00822383520797
Quantity per Package
2
Contains DI Package
00122383520798
Package Discontinue Date
July 10, 2017
Package Status
Not 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 |