Duns Number:008965063
Device Description: Compression Sleeve - Knee S/M
Catalog Number
-
Brand Name
WALGREEN
Version/Model Number
107249
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2020
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
7fc8e705-c359-43e7-81db-9e58b6467422
Public Version Date
August 16, 2021
Public Version Number
3
DI Record Publish Date
July 01, 2020
Package DI Number
01049022125925
Quantity per Package
6
Contains DI Package
00049022125926
Package Discontinue Date
October 31, 2020
Package Status
Not in Commercial Distribution
Package Type
Inner Pack
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 |