Duns Number:315917492
Device Description: JOBST RELAX CCL2/KNEE HIGH/OPEN TOE/ZIPPER/ROSE
Catalog Number
-
Brand Name
JOBST Relax
Version/Model Number
76097-00003-00
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)
-
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
MDR
Product Code Name
BINDER, MEDICAL, THERAPEUTIC
Public Device Record Key
6a54f172-abf3-4edd-8b1f-db6e68773515
Public Version Date
July 07, 2020
Public Version Number
4
DI Record Publish Date
February 09, 2018
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 |