Device
Dornier AXIS II E URS FLEX EU - Ureteroscope
Manufacturer
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDTECH AMERICA, INC.
Model: Dornier AXIS II E URS FLEX EU - Ureteroscope
Catalog: AX20408
DI: 00810116023387
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
457306e8-e5ad-4bd9-80b5-13ce2d82b5f5
Distribution Status:
In Commercial Distribution
DUNS Number:
130789944
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810116023387
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64074
Name: Flexible video ureteroscope, single-use
Definition:
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.
FDA Product Codes
FGB
Ureteroscope And Accessories, Flexible/Rigid