Duns Number:038000253
Device Description: 0.018"(0.5MM)X 80CM MARKED NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Catalog Number
-
Brand Name
MODIFICATION TO VASCU PUNCTURE PICC GUIDEWIREMODIFICATION TO VASCU PUNCTURE PICC
Version/Model Number
MR190080
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"
Yes
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
4595289a-8554-4039-8bf0-122225768b70
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
50884908033569
Quantity per Package
4
Contains DI Package
30884908033565
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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 2560 |