Duns Number:008965063
Device Description: WALG STIRRUP ANKLE BRACE W/HT&CLD PADS
Catalog Number
-
Brand Name
WALGREENS
Version/Model Number
871055
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
IME
Product Code Name
Pack, Hot Or Cold, Reusable
Public Device Record Key
5d835a96-6b63-47a6-9c9a-7c41f5b7015c
Public Version Date
July 13, 2020
Public Version Number
1
DI Record Publish Date
July 03, 2020
Package DI Number
10049022176406
Quantity per Package
24
Contains DI Package
00049022176409
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 |