Duns Number:021717889
Device Description: Ureteral Access Sheath Set
Catalog Number
-
Brand Name
Navigator
Version/Model Number
M0062502070
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
FED
Product Code Name
endoscopic access overtube, gastroenterology-urology
Public Device Record Key
d8af380a-a0cc-4483-93ef-174fe80232d0
Public Version Date
November 18, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
08714729469605
Quantity per Package
5
Contains DI Package
08714729751526
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |