Duns Number:047025993
Device Description: Gel Thumb Support (White)
Catalog Number
-
Brand Name
Vive
Version/Model Number
SUP1084WHT
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
ILG
Product Code Name
Stocking, Elastic
Public Device Record Key
b303b2e6-4a3e-4a6d-88ae-05a80a405ccd
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
Package DI Number
10818323023500
Quantity per Package
100
Contains DI Package
00818323023503
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 480 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |