Duns Number:079506014
Device Description: 0.018" (0.47MM) X 45CM NITINOL GUIDEWIRE
Catalog Number
-
Brand Name
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
Version/Model Number
JT140184500
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
2948d507-c673-4ea8-910d-8e599fe5511d
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
April 13, 2018
Package DI Number
50810988021264
Quantity per Package
10
Contains DI Package
00810988021269
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 63 |