Duns Number:989772017
Device Description: Vein Irrigation Cannula Sterile
Catalog Number
FD-1006
Brand Name
Vein Irrigation Cannula DMC VIC Sterile
Version/Model Number
DMC VIC STERILE
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
K000704,K000704,K000704
Product Code
GBX
Product Code Name
Catheter, Irrigation
Public Device Record Key
9c6b172e-3d6b-4ab2-a8ee-bf2d9a3161d6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 10, 2016
Package DI Number
05391530750110
Quantity per Package
21
Contains DI Package
05391530750103
Package Discontinue Date
-
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 29 |