PREXION EVOLVE 16000004487

GUDID 07899581344985

Panoramic Only

Alliage S/A Indústrias Médico Odontológica

Cone beam computed tomography system, head/neck

Primary Device ID	07899581344985
NIH Device Record Key	5afd3e10-839f-4ea6-add9-3de45dddf2e6
Commercial Distribution Status	In Commercial Distribution
Brand Name	PREXION EVOLVE
Version Model Number	AXR90
Catalog Number	16000004487
Company DUNS	898231451
Company Name	Alliage S/A Indústrias Médico Odontológica
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	true
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 Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899581344985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223816

FDA Product Code

OAS	X-Ray, Tomography, Computed, Dental