Duns Number:130789944
Device Description: Single Use Digital Flexible Ureteroscope, Max. Insertion Portion Width: 3.1 mm, Max Insert Single Use Digital Flexible Ureteroscope, Max. Insertion Portion Width: 3.1 mm, Max Insertion Channel Width: 1.2 mm, Bending Angle: -275° - +275°, Working Length: 650 mm
Catalog Number
AX93US31B
Brand Name
Dornier MedTech
Version/Model Number
Axis Ureteroscope
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
FGB
Product Code Name
Ureteroscope And Accessories, Flexible/Rigid
Public Device Record Key
18c3f82e-fb41-43b6-863c-dd62f30d60a9
Public Version Date
October 17, 2022
Public Version Number
3
DI Record Publish Date
January 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |