Model: NB-20-110
DI: 00860000321389
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Neuroblade System
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0690e7f7-4efd-421b-82b2-c87d14c73fd6
Distribution Status:
In Commercial Distribution
DUNS Number:
658832644
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
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:
Carton
Item #1 - Device ID:
10860000321386
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00860000321389
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00860000321389
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Box
Item #3 - Device ID:
20860000321383
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
4
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10860000321386
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 63706
Name: Surgical irrigation/aspiration cannula, illuminating, single-use
Definition:
An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It has a built-in light or fibreoptic bundle for illumination. The device may incorporate a handle with side valve(s)/hole(s) for the control of irrigation/aspiration, and may be provided with a stylet, sheath, and/or connection tubing. This is a single-use device.
FDA Product Codes
GWG
Endoscope, Neurological
GEI
Electrosurgical, Cutting & Coagulation & Accessories
Premarket Submissions
Submission Number:
K230125
Supplement Number:
000