Duns Number:431221795
Device Description: SOCKS FOR YOU FREEDOM JAZZ, SIZE XXL, BIANCO, ANATOMIC COMPRESSION UNISEX LOW CUT SOCK MAD SOCKS FOR YOU FREEDOM JAZZ, SIZE XXL, BIANCO, ANATOMIC COMPRESSION UNISEX LOW CUT SOCK MADE OF PRECIOUS BAMBOO YARN
Catalog Number
0591A4
Brand Name
SOLIDEA
Version/Model Number
065210
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
FQL
Product Code Name
Stocking, Medical Support (For General Medical Purposes)
Public Device Record Key
fdf34301-fd76-4420-8bd2-b467536f3a49
Public Version Date
February 26, 2021
Public Version Number
1
DI Record Publish Date
February 18, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2515 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 751 |