Duns Number:079105071
Device Description: Venacure EVLT NeverTouch Direct Introducer Sheath
Catalog Number
-
Brand Name
VenaCure
Version/Model Number
16510001
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
K170695
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
243f68cd-a11a-41b4-9b95-0eea40720ae0
Public Version Date
April 25, 2019
Public Version Number
5
DI Record Publish Date
July 24, 2017
Package DI Number
H787165100011
Quantity per Package
10
Contains DI Package
H787165100010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 203 |