Duns Number:022348156
Device Description: Vasoview EVH Accsessory Pack
Catalog Number
VH-2004
Brand Name
Vasoview EVH Accsessory Pack
Version/Model Number
VH-2004
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041981,K041981,K041981
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
1fa3d86a-3bdf-4cbe-a9f6-6dabebe12828
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
00607567700370
Quantity per Package
5
Contains DI Package
00607567700376
Package Discontinue Date
May 29, 2018
Package Status
Not in Commercial Distribution
Package Type
5 pack box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 184 |