Duns Number:047025993
Device Description: Folding Cane Teal
Catalog Number
-
Brand Name
VIVE
Version/Model Number
MOB1001TEAL
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
0dae70e6-d0c0-451b-8660-4952b0166494
Public Version Date
February 28, 2019
Public Version Number
1
DI Record Publish Date
January 28, 2019
Package DI Number
10818323026044
Quantity per Package
20
Contains DI Package
00818323026047
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 |