Duns Number:867673159
Device Description: Walkers, All Types1-Button Product Description: YadSarah,Walker,Adult, 1 Button, 2/cs
Catalog Number
-
Brand Name
Drive
Version/Model Number
YS10202-2
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
ITJ
Product Code Name
WALKER, MECHANICAL
Public Device Record Key
93618ef7-40bf-4934-90e0-bd4092f99163
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 25, 2019
Package DI Number
00822383529868
Quantity per Package
2
Contains DI Package
50822383529863
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 |