Duns Number:008965063
Device Description: WALG BANDAGE W/CLIPS 4"
Catalog Number
-
Brand Name
Well at Walgreens
Version/Model Number
307751
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
1cb3d91e-b7f7-434b-8fb9-65ab05d8141b
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
May 22, 2020
Package DI Number
10049022739243
Quantity per Package
72
Contains DI Package
00049022739246
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 |