Intraoral Dental Digital Imaging Sensor 16000004137

GUDID 07899581340277

Size 1

Alliage S/A Indústrias Médico Odontológica

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Primary Device ID	07899581340277
NIH Device Record Key	f79d7500-fcd8-45ee-afd8-d64699d56a03
Commercial Distribution Status	In Commercial Distribution
Brand Name	Intraoral Dental Digital Imaging Sensor
Version Model Number	Saevo Slim
Catalog Number	16000004137
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 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal
Storage Environment Temperature	Between 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 79.7 KiloPascal and 101.3 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899581340277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230732

FDA Product Code

EHD	Unit, X-Ray, Extraoral With Timer

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-10-26
Device Publish Date	2023-10-18

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