Duns Number:038000253
Device Description: 0.018" (0.47MM) X 80CM0.018" (0. MARKED NITINOL WIRE WITHMARKED N RADIOPAQUE TIP WITHRADIO 0.018" (0.47MM) X 80CM0.018" (0. MARKED NITINOL WIRE WITHMARKED N RADIOPAQUE TIP WITHRADIOPAQUE TI HYDROPHILIC COATINGHYDROPHILIC C
Catalog Number
MRI19180801
Brand Name
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREMODIFICATION TO VASCUPUNCTURE PICC G
Version/Model Number
MRI19180801
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 2021
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
e6870e33-8542-495f-af34-ac6dc2fb2ff8
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
July 10, 2019
Package DI Number
30884908032315
Quantity per Package
10
Contains DI Package
00884908032314
Package Discontinue Date
January 29, 2021
Package Status
Not in Commercial Distribution
Package Type
inner 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 |