Duns Number:189738719
Device Description: A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns)
Catalog Number
862NXLO99
Brand Name
860 Select Comfort
Version/Model Number
862N
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
Yes
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
718a91af-62cd-4b41-b207-8e88d0dd7d0b
Public Version Date
February 02, 2021
Public Version Number
1
DI Record Publish Date
January 25, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4554 |