SXR / Saevo 16000004380

GUDID 07899581340789

Tomography only (MFOV)

Alliage S/A Indústrias Médico Odontológica

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Primary Device ID	07899581340789
NIH Device Record Key	42dfd224-87f5-42e7-83cd-d6def2b046fb
Commercial Distribution Status	In Commercial Distribution
Brand Name	SXR / Saevo
Version Model Number	AXR120 B
Catalog Number	16000004380
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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899581340789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223816

FDA Product Code

OAS	X-Ray, Tomography, Computed, Dental