Duns Number:044611812
Device Description: Navarre Universal Drainage Catheter with Nitinol, Locking Pigtail, 6 Fr x 30 cm
Catalog Number
NNU6LPT
Brand Name
Navarre
Version/Model Number
NNU6LPT
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
fa521e65-0695-486a-b3fa-6fb6a8d6f0a3
Public Version Date
October 25, 2022
Public Version Number
1
DI Record Publish Date
October 17, 2022
Package DI Number
10801741000345
Quantity per Package
5
Contains DI Package
00801741000348
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |