Duns Number:560455084
Device Description: Be made of 70% Nylon and 30% Spandex, prevent varicose veins with graduated compression fr Be made of 70% Nylon and 30% Spandex, prevent varicose veins with graduated compression from ankle upwards. Various colors and specifications are available.
Catalog Number
-
Brand Name
Huibo Medical
Version/Model Number
II-AD-M
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)
-
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
4fd7ebdb-1c03-41e5-adbb-66cf72a9b89c
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
January 21, 2020
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |