NaviENT system with Kit

GUDID 07540209955112

Navient ENT system with kit

ClaroNav Kolahi Inc

Neurological stereotactic surgery system

Primary Device ID	07540209955112
NIH Device Record Key	7217eed2-f7e0-4e40-a4ae-e80573f2b048
Commercial Distribution Status	In Commercial Distribution
Brand Name	NaviENT system with Kit
Version Model Number	955-NE-NE
Company DUNS	203466065
Company Name	ClaroNav Kolahi 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	true
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

Operating and Storage Conditions

Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -25 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540209955112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163439

FDA Product Code

HAW	Neurological Stereotaxic Instrument