Duns Number:008965063
Device Description: WALG COPPER ELBOW SUPPORT
Catalog Number
-
Brand Name
WALGREENS
Version/Model Number
444936
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"
Yes
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
IOY
Product Code Name
Support, Arm
Public Device Record Key
5868d3e3-4a28-42c0-aae3-358f9aac8235
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 13, 2021
Package DI Number
10049022164670
Quantity per Package
24
Contains DI Package
00049022164673
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 |