Duns Number:079105071
Device Description: High Performance Micro Guidewire, NITINOL, ANGLED, 7 CM, Coil INTERMEDIATE
Catalog Number
-
Brand Name
Nit-Vu
Version/Model Number
05800103
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
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
27f7c3e5-74aa-49fa-92c2-3f8ef0941bc3
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
September 19, 2016
Package DI Number
H787058001035
Quantity per Package
3
Contains DI Package
H787058001030
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 |