Duns Number:431221795
Device Description: WONDER MODEL CCL.1, SIZE M, BLU SCURO, GRADUATED COMPRESSION 18/21 mmHg TIGHTS
Catalog Number
0418A8
Brand Name
SOLIDEA
Version/Model Number
61755
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
DWL
Product Code Name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Public Device Record Key
f13af190-8a04-453f-ba1f-0af8b914bda5
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
June 04, 2019
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 |