Duns Number:058716649
Device Description: Tri-Pak (Includes:125 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tub Tri-Pak (Includes:125 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube)(CT - 125ML ENV/VIST SYR KIT W/QFT,LPCT)(60728613)
Catalog Number
CTP-125-FLS
Brand Name
CT TRI-PAK Sterile Disposable Syringe
Version/Model Number
CTP-125-FLS
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
K934086,K934086
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
07272ef8-3b26-4f9e-8f6f-72071e5a9b85
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10616258005482
Quantity per Package
50
Contains DI Package
00616258005485
Package Discontinue Date
December 31, 9999
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 360 |