Shatkin FIRST

GUDID 10817417021248

Implant, Endo and Oral Surgery System

ASEPTICO, INC.

Dental surgical power tool motor, electric

Primary Device ID	10817417021248
NIH Device Record Key	35d07f2f-ac8d-4c26-818b-c9b2e7af777b
Commercial Distribution Discontinuation	2032-11-02
Commercial Distribution Status	In Commercial Distribution
Brand Name	Shatkin FIRST
Version Model Number	AEU-7000E-SFI-70V
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	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com
Phone	14254873157
Email	Regulatory@aseptico.com

Operating and Storage Conditions

Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817417021248 [Primary]

FDA Product Code

EKX	Handpiece, Direct Drive, Ac-Powered