Model: MUR-000012
Catalog: MUR-000012
DI: 10810068811060
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
Guided Percutaneous Access Needle and accessories
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5fcd8767-71cb-4c35-870c-79882eda31ee
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:
10810068811060
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Shelf Box
Item #2 - Device ID:
20810068811067
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
10810068811060
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Shipper
Item #3 - Device ID:
30810068811064
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
5
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10810068811060
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 61503
Name: Nephrostomy catheter introduction needle
Definition:
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access the kidney during nephrostomy catheter introduction for urinary drainage. It is intended to enable introduction of a guidewire (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. It may include an intraluminal stylet intended to add rigidity to the needle during introduction. This is a single-use device.
FDA Product Codes
GCB
Needle, Catheter
Premarket Submissions
Submission Number:
K213334
Supplement Number:
000