Duns Number:008965063
Device Description: WALG CRUTCH ACCESSORY KIT(2 Arm Cushions, 2 Hand Grips, 2 Tips)
Catalog Number
-
Brand Name
WALGREENS
Version/Model Number
586508
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
INP
Product Code Name
Tips And Pads, Cane, Crutch And Walker
Public Device Record Key
24eafd81-28c9-48eb-baa8-ea16f8bd664c
Public Version Date
June 12, 2020
Public Version Number
1
DI Record Publish Date
June 04, 2020
Package DI Number
10311917212712
Quantity per Package
8
Contains DI Package
00311917212715
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 |