FMS 283573

GUDID 10886705017010

FMS 5-Way Foot Pedal

Medos International Sàrl

Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical
Primary Device ID10886705017010
NIH Device Record Keyf4969d69-077e-4b31-87b0-73ef2846ae16
Commercial Distribution StatusIn Commercial Distribution
Brand NameFMS
Version Model Number283573
Catalog Number283573
Company DUNS482661753
Company NameMedos International Sàrl
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

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste from Electrical and Electronic Equipment
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705017010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-05-13
Device Publish Date2015-09-01

On-Brand Devices [FMS]

20886705000781FMS 3.0mm Mini Round Tornado Burr Plus
20886705000019FMS 2.0mm Mini Round Tornado Burr Plus
10886705030743FMS Fluid Management System Tornado Micro II Hand Controlled Shaver Handpiece Shaver handpiece w
10886705030736FMS Fluid Management System Tornado Micro II No-Button Shaver Handpiece Shaver handpiece without
10886705017010FMS 5-Way Foot Pedal
10886705016990FMS Remote Control
10886705020485FMS VUE Fluid Management System FMS CONNECT Interface Cable
20886705027276FMS Mini Ultra-Aggressive Blade Plus 3.5mm
20886705027269FMS Mini Aggressive Blade Plus 3.5mm
20886705027252FMS Mini Full Radius Blade Plus 3.5mm
20886705027245FMS Ultra-Aggressive Blade Plus 3.5mm
20886705027238FMS Aggressive Blade Plus 3.5mm
20886705027221FMS Full Radius Blade Plus 3.5mm
20886705027191FMS Mini Ultra-Aggressive Blade Plus 2.7mm
20886705027184FMS Mini Full Radius Blade Plus 2.7mm
20886705025975FMS XL CURVED MULTI BLADE PLUS 4.2MM
20886705025968FMS CURVED MULTI BLADE PLUS 4.2MM
20886705025951FMS XL CURVED FULL RADIUS BLADE PLUS 4.2MM
20886705025944FMS XL CURVED AGGRESSIVE BLADE PLUS 4.2MM
20886705025937FMS CURVED FULL RADIUS BLADE PLUS 4.2MM
20886705025920FMS CURVED AGGRESSIVE BLADE PLUS 4.2MM
20886705025913FMS XL CURVED ULTRA-AGGRESSIVE BLADE PLUS 4.2MM
20886705025906FMS CURVED ULTRA-AGGRESSIVE BLADE PLUS 4.2MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.