MIS AEU-6000MIS-70V

GUDID 10817417021101

Implant / Endodontic Dental Systems

ASEPTICO, INC.

Dental surgical power tool motor, electric
Primary Device ID10817417021101
NIH Device Record Key5952da05-abdc-45db-a69b-a40cba7af14f
Commercial Distribution Discontinuation2032-11-02
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIS
Version Model NumberAEU-6000MIS-70V
Catalog NumberAEU-6000MIS-70V
Company DUNS016853348
Company NameASEPTICO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone14254873157
EmailRegulatory@aseptico.com
Phone14254873157
EmailRegulatory@aseptico.com
Phone14254873157
EmailRegulatory@aseptico.com
Phone14254873157
EmailRegulatory@aseptico.com
Phone14254873157
EmailRegulatory@aseptico.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110817417021101 [Primary]

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10817417021101]

Moist Heat or Steam Sterilization


[10817417021101]

Moist Heat or Steam Sterilization


[10817417021101]

Moist Heat or Steam Sterilization


[10817417021101]

Moist Heat or Steam Sterilization


[10817417021101]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-16
Device Publish Date2022-11-08

On-Brand Devices [MIS]

10817417021101Implant / Endodontic Dental Systems
10817417021279Implant, Endo and Oral Surgery System
10817417021231Implant, Endo and Oral Surgery System

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