Model: MUR-000016
Catalog: MUR-000016
DI: 10810068811107
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
Irrigation cartridge and tubing
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5d74fbe8-f2ad-4c01-96ac-e522afc97cc4
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:
10810068811107
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Shelf Box
Item #2 - Device ID:
20810068811104
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
5
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
10810068811107
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Shipper Box
Item #3 - Device ID:
30810068811101
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
5
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10810068811107
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 43415
Name: Urological irrigation system
Definition:
An assembly of devices intended for the infusion of sterile fluids (e.g., saline, water) into the ureter and upper urinary tract to irrigate these passageways in a controlled manner during a diagnostic and /or a therapeutic urological procedure; including a urinary tract endoscopic procedure. It typically consists of a mains electricity (AC-powered) pump, tubing, connectors and other items that enable the pressure, temperature, or flow of water to be controlled.
FDA Product Codes
FGB
Ureteroscope And Accessories, Flexible/Rigid
Premarket Submissions
Submission Number:
K213334
Supplement Number:
000