Home GUDID 00856853006030 Fujifilm Surgical System
Primary DI 00856853006030
Brand Fujifilm Surgical System
Company FUJIFILM NEW DEVELOPMENT U.S.A., INC.
Model XL-4450FN
Device description Light Source
Published 2017-05-17
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GCJ Laparoscope, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00856853006030 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00856853006030 00856853006030 856853006030 0856853006030
GMDN Terms# Term, Definition table Term Definition Endoscopic video image processing/light source system A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 30 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 45 Degrees Celsius
Regulatory Flags# DUNS number 005065629 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00856853006016 Fujifilm Surgical System EL-580FN 2017-05-17 00856853006009 InterLock Trocar Rev A 1001 2017-05-17 00856853006023 Fujifilm Surgical System VP-4440FN 2017-05-17 00856853006047 Fujifilm Surgical System RC-4440FN 2017-05-17
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