Duns Number:005179271
Device Description: 2-100ml syringes, 1-96" Y coiled tubing with dual check valves, 1 large spike, 1 small spi 2-100ml syringes, 1-96" Y coiled tubing with dual check valves, 1 large spike, 1 small spike YM
Catalog Number
-
Brand Name
Medical Imaging Solutions Intl.
Version/Model Number
400302D
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152906,K152906
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
2aa36073-b237-4f83-a5e6-dd7efff972ce
Public Version Date
January 25, 2021
Public Version Number
1
DI Record Publish Date
January 15, 2021
Package DI Number
10850014500358
Quantity per Package
50
Contains DI Package
00850014500351
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |