Model: MUR-000011
Catalog: MUR-000011
DI: 10810068811053
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Ureteroscope and accessories
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
04fb028c-42ae-499c-8e19-50c0a09b5254
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:
10810068811053
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Shelf Box
Item #2 - Device ID:
20810068811050
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
10810068811053
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Shipper
Item #3 - Device ID:
30810068811057
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
1
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
20810068811050
Item #3 - Device ID 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
LJH
System, Irrigation, Urological
Premarket Submissions
Submission Number:
K213334
Supplement Number:
000