Model: 66293
DI: 08720892330826
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d676530c-65b4-4b60-a2f4-a0717f5fee06
Distribution Status:
In Commercial Distribution
DUNS Number:
491124978
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
08720892330826
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
48720892330824
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
4
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
08720892330826
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 32568
Name: Neurological stereotactic surgery system
Definition:
An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
FDA Product Codes
HAW
Neurological Stereotaxic Instrument
Premarket Submissions
Submission Number:
K250893
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling Low - @attributes - Value:
32
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value:
104
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
10
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
85
Item #2 - Storage Handling Type:
Handling Environment Humidity