Duns Number:079105071
Device Description: Mariner Hydrophilic Coated Angiographic Catheter, Berenstein, Braided
Catalog Number
-
Brand Name
Mariner
Version/Model Number
51707126
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
K112452,K161596,K173762
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
9a0ec4c5-996e-4033-9e59-9a570ca8821c
Public Version Date
December 19, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
H787517071265
Quantity per Package
5
Contains DI Package
H787517071260
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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. | 203 |