Duns Number:867673159
Device Description: Personal CareAids to Daily Living Product Description: Knobble,2EA=1PR
Catalog Number
-
Brand Name
Drive
Version/Model Number
4304
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2019
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
a7235613-a0e2-4632-addf-f6a89a119ef0
Public Version Date
June 02, 2020
Public Version Number
2
DI Record Publish Date
June 21, 2019
Package DI Number
50779709043049
Quantity per Package
60
Contains DI Package
00779709043044
Package Discontinue Date
June 22, 2019
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 |