Duns Number:926684994
Device Description: Kodama Catheter, p/n 701470-001Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Ex Kodama Catheter, p/n 701470-001Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag, IFU
Catalog Number
-
Brand Name
ACIST Kodama® Coronary Imaging Catheter
Version/Model Number
017788
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
OBJ
Product Code Name
Catheter, Ultrasound, Intravascular
Public Device Record Key
0a83a139-4e71-49cf-a4c9-92c6584f458a
Public Version Date
March 04, 2020
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
30841716101213
Quantity per Package
5
Contains DI Package
10841716100755
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 193 |