FMS 283573

GUDID 10886705017010

FMS 5-Way Foot Pedal

Medos International Sàrl

Foot-switch, electrical

Primary Device ID	10886705017010
NIH Device Record Key	f4969d69-077e-4b31-87b0-73ef2846ae16
Commercial Distribution Status	In Commercial Distribution
Brand Name	FMS
Version Model Number	283573
Catalog Number	283573
Company DUNS	482661753
Company Name	Medos International Sàrl
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705017010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K954465

FDA Product Code

HRX	ARTHROSCOPE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-05-13
Device Publish Date	2015-09-01

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