Duns Number:690543319
Device Description: NAVICROSS Support Catheter
Catalog Number
PN*NA18153H
Brand Name
NAVICROSS
Version/Model Number
NC18151
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
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
c6952524-8131-4dfd-a42a-b5b89b5b8193
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
April 25, 2018
Package DI Number
54987892077314
Quantity per Package
5
Contains DI Package
04987892077319
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |