Duns Number:024954518
Device Description: VIPERSLIDE, 100ML BAG, 10 PK
Catalog Number
72031-01
Brand Name
Viperslide
Version/Model Number
VPR-SLD2
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
-
Product Code
MCX
Product Code Name
Catheter, Coronary, Atherectomy
Public Device Record Key
38b3a3f1-a891-44a1-b1d0-48ac2d4255fb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2014
Package DI Number
30852528005125
Quantity per Package
10
Contains DI Package
10852528005121
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 123 |
| 3 | A medical device with high risk that requires premarket approval | 15 |