Duns Number:151047370
Device Description: Quick-Cross™Select Support Catheter
Catalog Number
518-087
Brand Name
Quick-Cross™Select
Version/Model Number
518-087AB
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"
-
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
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
a4722d93-7722-4018-8100-d3b3c14f64cf
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
September 04, 2015
Package DI Number
20813132021737
Quantity per Package
5
Contains DI Package
00813132021733
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 251 |
3 | A medical device with high risk that requires premarket approval | 126 |