Posterior Cleanflow Matrices GW-PST-OMTX

GUDID 00858395006745

Posterior Cleanflow Matrices (10 Pack)

SONENDO, INC.

Dental delivery system instrument unit, electric
Primary Device ID00858395006745
NIH Device Record Keycc210e0b-2b48-40c6-8c8e-df0301fb2b47
Commercial Distribution StatusIn Commercial Distribution
Brand NamePosterior Cleanflow Matrices
Version Model NumberFG-013-00007
Catalog NumberGW-PST-OMTX
Company DUNS828894373
Company NameSONENDO, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com

Operating and Storage Conditions

Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100858395006738 [Primary]
GS100858395006745 [Unit of Use]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-02
Device Publish Date2022-10-25

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00810209420475 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 10/.06, 31mm
00810209420536 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.04, 31mm
00810209420543 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 21mm
00810209420550 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 25mm
00810209420567 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 31mm

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