Catalog Number
-
Brand Name
VIVE
Version/Model Number
MOB1003RED
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
IPS
Product Code Name
Cane
Public Device Record Key
8b41f32f-79be-403a-99bc-259de7f9900c
Public Version Date
March 04, 2019
Public Version Number
1
DI Record Publish Date
January 31, 2019
Package DI Number
10818323026204
Quantity per Package
4
Contains DI Package
00818323026207
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 |