Duns Number:058716649
Device Description: Stellant 60" low pressure connector tube with six-inch T-connector(CT - 60" T-CONNECT TUBI Stellant 60" low pressure connector tube with six-inch T-connector(CT - 60" T-CONNECT TUBING,PT,SSS-LP-60-T)(60729040)
Catalog Number
SSS-LP-60-T
Brand Name
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube
Version/Model Number
SSS-LP-60-T
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
K023183,K023183
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
61afa7f7-12c5-443b-8015-89b7fb44569c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10616258005260
Quantity per Package
50
Contains DI Package
00616258005263
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 |