Duns Number:047025993
Device Description: Memory Foam Insoles (Small)
Catalog Number
-
Brand Name
ViveSole
Version/Model Number
INS1046S
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
KYS
Product Code Name
Insoles, Medical
Public Device Record Key
90dceb3b-5ce9-407d-a892-fb6d23f3d1ca
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
10810041983357
Quantity per Package
50
Contains DI Package
00810041983350
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 |