Duns Number:024954518
Device Description: ViperWire, Advance, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Catalog Number
7-10035-01
Brand Name
Extended Length ViperWire Advance
Version/Model Number
VPR-GW-EL14
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
MCW
Product Code Name
Catheter, Peripheral, Atherectomy
Public Device Record Key
f828dd7a-a15d-4723-91ba-b284634fc7d2
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
December 14, 2017
Package DI Number
30852528005453
Quantity per Package
5
Contains DI Package
10852528005459
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 |