Duns Number:431221795
Device Description: SOCKS FOR YOU BAMBOO FLY HAPPY BLUE, SIZE XL, ROSSO, GRADUATED COMPRESSION 18/24 mmHg UNIS SOCKS FOR YOU BAMBOO FLY HAPPY BLUE, SIZE XL, ROSSO, GRADUATED COMPRESSION 18/24 mmHg UNISEX MID-CALF SOCK MADE OF PRECIOUS BAMBOO YARN WITH A BLUE COLOR CONTRAST FOR TOE, HEEL AND ELASTIC BAND
Catalog Number
0599A4
Brand Name
SOLIDEA
Version/Model Number
067153
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
0a24a347-1360-4c25-8f11-6e8c67f1f35e
Public Version Date
January 28, 2022
Public Version Number
1
DI Record Publish Date
January 20, 2022
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 |