Duns Number:008965063
Device Description: Compression Sleeve - Ankle S/M
Catalog Number
-
Brand Name
WALGREENS
Version/Model Number
107266
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
IQI
Product Code Name
Orthosis, Limb Brace
Public Device Record Key
b331a38a-5591-4b4f-8a0b-5ef17a11dc58
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 01, 2020
Package DI Number
10049022125954
Quantity per Package
24
Contains DI Package
00049022125957
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 |