SATELEC F57856

GUDID 03609820578569

General surgery ultrasonic control console

SATELEC

Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system Hard/soft-tissue ultrasonic surgical system
Primary Device ID03609820578569
NIH Device Record Key98f15c0c-3ea1-4674-bb7b-5c0b2cc9f5b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSATELEC
Version Model NumberPIEZOTOME SOLO M+ US
Catalog NumberF57856
Company DUNS381582196
Company NameSATELEC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS103609820578569 [Primary]
GS103609821578506 [Direct Marking]

FDA Product Code

JDXInstrument, Surgical, Sonic And Accessory/Attachment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-21
Device Publish Date2022-07-13

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03609820877082 - ACTEON2024-04-16 9mm cutting depth. Ultra-sharp and robust saw, equipped with four sharpened teeth, intended for in-depth cutting of cortical bon
03609820877099 - ACTEON2024-04-16 Long, ultra-sharp saw (15mm), slim profile, equipped with four sharpened teeth, intended for facilitating ramus grafts.
03609820877112 - ACTEON2024-04-16 Diamond-coated tip for vestibular bone window cut and for Smoothing sharp edges.

Trademark Results [SATELEC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SATELEC
SATELEC
73518874 1353896 Live/Registered
SOCIETE POUR LA CONCEPTION DES APPLICATIONS DES TECHNIQUES ELECTRONIQUES S.A.T.E.L.E.C.
1985-01-23

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