Aseptico AEU-525

GUDID 10817417021927

Transport III Portable electrical dental delivery system without scaler.

ASEPTICO, INC.

Dental delivery system
Primary Device ID10817417021927
NIH Device Record Key59e8b3e7-a0d8-4e8d-9fea-b66c2a5da2a2
Commercial Distribution Discontinuation2031-09-30
Commercial Distribution StatusIn Commercial Distribution
Brand NameAseptico
Version Model NumberAEU-525
Catalog NumberAEU-525
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

Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com
Phone425-487-3157
EmailRegulatory@aseptico.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110817417021927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUnit, Operative Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


[10817417021927]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-28
Device Publish Date2020-07-20

On-Brand Devices [Aseptico]

10817417021927Transport III Portable electrical dental delivery system without scaler.
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10817417020951Implant, Endo and Oral Surgery System
10817417020944Implant, Endo and Oral Surgery System
10817417020937Implant, Endo and Oral Surgery System
10817417020791Dental Implant Motor System
10817417020784Dental Implant Motor System
10817417021620Custom Cart Delivery
10817417021491Portable Hydraulic Dental Chair
10817417021484Portable Hydraulic Dental Chair
10817417021477Portable Hydraulic Dental Chair
10817417021460Portable Dental Chair
10817417021453Portable Pediatric Dental Chair
10817417021446Portable Dental Chair
10817417021422Portable Dental Chair
10817417020999Electric Operative Motor
10817417020982Implant/ Endodontic Dental System
10817417020975Implant / Endodontic Dental Systems
10817417020906Electronic Endodontic System
10817417020890Implant System
10817417020869Electronic Endodontic System
10817417020852Electronic Endodontic System
10817417020821Electronic Endodontic System
10817417020159Dental Implant Motor System
10817417020142Dental Implant Motor System
10817417020128Dental Implant Motor System
10817417020111Dental Implant Motor System
10817417020210Portable Dental Lamp
10817417020203Portable Dental Lamp
10817417022313AEU-350S GO ULTRA PORTABLE DENTAL SYSTEM W/ SCALER

Trademark Results [Aseptico]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASEPTICO
ASEPTICO
90235493 not registered Live/Pending
Aseptico, Inc
2020-10-05
ASEPTICO
ASEPTICO
85714165 4490233 Live/Registered
Aseptico, Inc.
2012-08-27
ASEPTICO
ASEPTICO
76416190 2693161 Live/Registered
Aseptico, Inc.
2002-05-31
ASEPTICO
ASEPTICO
76416189 2693160 Live/Registered
Aseptico, Inc.
2002-05-31
ASEPTICO
ASEPTICO
73686963 1523146 Dead/Cancelled
INSTA-CARE PHARMACEUTICAL SERVICES INC.
1987-09-29

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