Duns Number:809699023
Device Description: Angiographic Guidewire, Fixed Core, J Tip
Catalog Number
-
Brand Name
Navilyst
Version/Model Number
97000206
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 23, 2021
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
3622671d-6328-4974-b17c-0fe473f699df
Public Version Date
September 28, 2021
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
H965970002061
Quantity per Package
10
Contains DI Package
H965970002060
Package Discontinue Date
September 23, 2021
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 |