Duns Number:968903703
Device Description: GW N354002 NITREX V03
Catalog Number
-
Brand Name
NITREX™
Version/Model Number
N354002
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
K040345,K040345
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
dd17ef83-6a66-4767-a5f2-19c44370c08b
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
June 16, 2017
Package DI Number
00821684065556
Quantity per Package
3
Contains DI Package
00821684058404
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |