Duns Number:047025993
Device Description: Envelop 3/4 Small
Catalog Number
-
Brand Name
VIVE
Version/Model Number
INS1002S
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
KNP
Product Code Name
Orthosis, Corrective Shoe
Public Device Record Key
d79a8d1a-0c73-4d9c-b4a2-a7770d9e82d6
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
February 06, 2019
Package DI Number
10818323026457
Quantity per Package
50
Contains DI Package
00818323026450
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 |