Duns Number:315917492
Device Description: ELVAREX FORTE 3/KNEE HIGH/PROFILE-SLANT-OPEN TOE/DOTTED SILICONE BAND INSIDE, WITH SLIP FO ELVAREX FORTE 3/KNEE HIGH/PROFILE-SLANT-OPEN TOE/DOTTED SILICONE BAND INSIDE, WITH SLIP FORM/BLACK
Catalog Number
-
Brand Name
JOBST Elvarex
Version/Model Number
77425-01993-00
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
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
50f09fe4-da3a-478d-ba49-da94d1969e65
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
January 24, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13508 |