Model: 66-IT(IT2)-00778
Catalog: 66-IT(IT2)
DI: 00873263007785
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
microTargeting Insertion Tube with Stylet, nonsterile
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
032d7d41-652b-4ba4-ad13-a5c00ff8b706
Distribution Status:
In Commercial Distribution
DUNS Number:
108179458
Device Count:
1
DM Exempt:
Yes
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
Device ID:
00873263007785
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61854
Name: Intracerebral cannula, nonimplantable, reusable
Definition:
A nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
HAW
Neurological stereotaxic Instrument
Premarket Submissions
Submission Number:
K011775
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
95
Item #1 - Storage Handling Type:
Storage Environment Humidity
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
40
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
95
Item #3 - Storage Handling Type:
Handling Environment Humidity