Duns Number:809699023
Device Description: Angiographic Guidewire, Fixed Core, J Tip
Catalog Number
-
Brand Name
Navilyst
Version/Model Number
96000217
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 16, 2022
Issuing Agency
In HIBCC
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
3d51b5cb-f64f-40c7-8996-5943f0543d59
Public Version Date
May 18, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
H965960002171
Quantity per Package
5
Contains DI Package
H965960002170
Package Discontinue Date
May 13, 2022
Package Status
Not 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 | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |