microTargeting™ Multi-Oblique Tool Guide 66-MO-03

GUDID 00873263005484

Multi-Oblique Platform 2.2mm Tool Guide

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

Primary Device ID	00873263005484
NIH Device Record Key	680dc231-ec3a-4cd7-8720-1b9b7bca1014
Commercial Distribution Status	In Commercial Distribution
Brand Name	microTargeting™ Multi-Oblique Tool Guide
Version Model Number	66-MO-03-00548
Catalog Number	66-MO-03
Company DUNS	108179458
Company Name	FHC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com
Phone	+1(800)326-2905
Email	fhcinc@fh-co.com

Device Dimensions

Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter
Lumen/Inner Diameter	2.2 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263005484 [Primary]
GS1	00873263007143 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092192

FDA Product Code

HAW	Neurological stereotaxic Instrument