Fujifilm Surgical System

GUDID 00856853006016

FUJIFILM NEW DEVELOPMENT U.S.A., INC.

Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope

Primary Device ID	00856853006016
NIH Device Record Key	d5a282b8-a098-422c-ba9e-d498e7a44f88
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fujifilm Surgical System
Version Model Number	EL-580FN
Company DUNS	005065629
Company Name	FUJIFILM NEW DEVELOPMENT U.S.A., INC.
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	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856853006016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162836

FDA Product Code

GCJ	Laparoscope, General & Plastic Surgery