Device
Stone retrieval basket and introducer
Manufacturer
Auris Health, Inc.
Model: MUR-000015 Catalog: MUR-000015 DI: 10810068811091 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
Stone retrieval basket and introducer
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 5674438c-143c-4614-9800-cb9f4bfde241
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: 10810068811091
Item #1 - Device ID Type: Primary
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Pkg Type: Shelf Box
Item #2 - Device ID: 20810068811098
Item #2 - Pkg Status: In Commercial Distribution
Item #2 - Pkg Quantity: 1
Item #2 - Device ID Type: Package
Item #2 - Contains DINumber: 10810068811091
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Shipper Box
Item #3 - Device ID: 30810068811095
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 5
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 10810068811091
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 44333
Name: Urinary stone retrieval basket, single-use
Definition:
A manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.
FDA Product Codes
FFL
Dislodger, Stone, Basket, Ureteral, Metal
Premarket Submissions
Submission Number: K213334
Supplement Number: 000