Duns Number:079814353
Device Description: MR 60/60mL LF Dual Syringe Kit Includes (1) 90" Y-coiled tubing (1) large spike (1) small MR 60/60mL LF Dual Syringe Kit Includes (1) 90" Y-coiled tubing (1) large spike (1) small spike
Catalog Number
128-200301
Brand Name
Ecomed Angiographic
Version/Model Number
128-200301
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
616b8edc-94f0-42ac-a149-8554a2094487
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2017
Package DI Number
10855009006105
Quantity per Package
50
Contains DI Package
00855009006108
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. | 11 |