Duns Number:008965063
Device Description: 5" Walker Wheels with Glide Caps, 1 Pair
Catalog Number
WRX926097RV1
Brand Name
Walgreens
Version/Model Number
926097
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"
Yes
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
ITJ
Product Code Name
Walker, Mechanical
Public Device Record Key
60a9cfaa-83c2-45ab-9e2b-c0db638e22c4
Public Version Date
July 22, 2020
Public Version Number
1
DI Record Publish Date
July 14, 2020
Package DI Number
10311917181513
Quantity per Package
6
Contains DI Package
00311917181516
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |