Duns Number:047025993
Device Description: Bamboo Wrist Medium
Catalog Number
-
Brand Name
VIVE
Version/Model Number
SUP1016
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
ITQ
Product Code Name
Joint, Knee, External Brace
Public Device Record Key
f60e1ff6-f58b-49e4-9fef-6dcaa8115f56
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 23, 2019
Package DI Number
10818323029465
Quantity per Package
1
Contains DI Package
00818323029468
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 |