Device
Mini-PCNL Catheter, Percutaneous Sheath, dilation set and accessories.
Manufacturer
Auris Health, Inc.
Auris Health, Inc.
Model: MUR-000014
Catalog: MUR-000014
DI: 10810068811084
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
Mini-PCNL Catheter, Percutaneous Sheath, dilation set and accessories.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
35c271b7-fd26-41fd-a19f-f90820393ca5
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 - Pkg Type:
Shelf carton
Item #1 - Device ID:
20810068811081
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10810068811084
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10810068811084
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 10735
Name: Nephrostomy catheter
Definition:
A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.
FDA Product Codes
GCB
Needle, Catheter
Premarket Submissions
Submission Number:
K213334
Supplement Number:
000