Duns Number:044611812
Device Description: Navarre Percutaneous Biliary Drainage Catheter with Nitinol, 12F Locking Pigtail
Catalog Number
NBD12
Brand Name
Navarre
Version/Model Number
NBD12
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
FGE
Product Code Name
CATHETER, BILIARY, DIAGNOSTIC
Public Device Record Key
b4a42ec0-cd61-4df8-8966-98c56884336f
Public Version Date
September 08, 2022
Public Version Number
4
DI Record Publish Date
November 20, 2015
Package DI Number
10801741036856
Quantity per Package
5
Contains DI Package
00801741036859
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 |