Straumann Sirios

GUDID 06973993442222

Intraoral Scanner

Alliedstar Medical Equipment Co., Ltd.

Intraoral optical scanning system

Primary Device ID	06973993442222
NIH Device Record Key	bb60d7a4-cc76-47cf-ab62-23375b3ed659
Commercial Distribution Status	In Commercial Distribution
Brand Name	Straumann Sirios
Version Model Number	ST 200E
Company DUNS	703541803
Company Name	Alliedstar Medical Equipment Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	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 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973993442222 [Primary]

FDA Product Code

NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations