Duns Number:031108704
Device Description: Urological guidewire
Catalog Number
VNTBR-039
Brand Name
ZipWire
Version/Model Number
M0066802231
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
EYA
Product Code Name
Stylet, Ureteral
Public Device Record Key
97638c53-2f9a-4712-9df9-80d0de4355bb
Public Version Date
July 08, 2020
Public Version Number
1
DI Record Publish Date
June 30, 2020
Package DI Number
10816349011839
Quantity per Package
5
Contains DI Package
00816349011832
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 151 |
| 3 | A medical device with high risk that requires premarket approval | 8 |