Aseptico AEU-1000

GUDID 10817417020739

Dental Implant Motor System is a drive system for instruments and tools used in dentistry for implant procedures.

ASEPTICO, INC.

Dental surgical power tool motorized handpiece/set, electric

Primary Device ID	10817417020739
NIH Device Record Key	387a38ab-a56d-4f57-a71a-0d3a5e225354
Commercial Distribution Discontinuation	2032-07-01
Commercial Distribution Status	In Commercial Distribution
Brand Name	Aseptico
Version Model Number	AEU-1000
Catalog Number	AEU-1000
Company DUNS	016853348
Company Name	ASEPTICO, INC.
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	false
Serial Number	true
Manufacturing Date	false
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

Customer Support Contacts

Phone	425-487-3157
Email	Regulatory@aseptico.com
Phone	425-487-3157
Email	Regulatory@aseptico.com
Phone	425-487-3157
Email	Regulatory@aseptico.com
Phone	425-487-3157
Email	Regulatory@aseptico.com
Phone	425-487-3157
Email	Regulatory@aseptico.com
Phone	425-487-3157
Email	Regulatory@aseptico.com
Phone	425-487-3157
Email	Regulatory@aseptico.com
Phone	425-487-3157
Email	Regulatory@aseptico.com

Operating and Storage Conditions

Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817417020739 [Primary]

FDA Product Code

EKX	Handpiece, Direct Drive, Ac-Powered