Device
Ureteroscope valve
Manufacturer
Auris Health, Inc.
Model: MUR-000026 Catalog: MUR-000026 DI: 10810068811121 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-04 Current Version: 2026-05-12
Description
Ureteroscope valve
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 11e8bed5-6024-4d39-b6f4-278b4b0dc1db
Distribution Status: In Commercial Distribution
DUNS Number: 015823456
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: Yes
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
Item #1 - Device ID: 10810068811121
Item #1 - Device ID Type: Primary
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Pkg Type: Shelf Box
Item #2 - Device ID: 20810068811128
Item #2 - Pkg Status: In Commercial Distribution
Item #2 - Pkg Quantity: 15
Item #2 - Device ID Type: Package
Item #2 - Contains DINumber: 10810068811121
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Shipper Box
Item #3 - Device ID: 30810068811125
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 15
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 10810068811121
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 60758
Name: Endoscope air/water valve, single-use
Definition:
A device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. This is a single-use device.
FDA Product Codes
FGB
Ureteroscope And Accessories, Flexible/Rigid
Premarket Submissions
Submission Number: K213334
Supplement Number: 000