Duns Number:047025993
Device Description: Compression Gloves
Catalog Number
-
Brand Name
VIVE
Version/Model Number
SUP1019
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 30, 2022
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
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
adf0cf8c-bc9b-446d-9260-978fbb7893b6
Public Version Date
October 04, 2022
Public Version Number
3
DI Record Publish Date
July 03, 2019
Package DI Number
10818323028123
Quantity per Package
100
Contains DI Package
00818323028126
Package Discontinue Date
November 30, 2022
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 |