Duns Number:008965063
Device Description: WALG HINGED KNEE BRACE S/M
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
848777
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITQ
Product Code Name
Joint, Knee, External Brace
Public Device Record Key
0744772e-f494-49d9-a58a-acb429f16bd4
Public Version Date
August 30, 2022
Public Version Number
3
DI Record Publish Date
May 09, 2020
Package DI Number
10049022997650
Quantity per Package
12
Contains DI Package
00049022997653
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |