FUJIFILM CORPORATION

Address:798 MIYANODAI KAISEI-MACHI,ASHIGARAKAMI-GUN Kanagawa,JP

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Adaptor, bulbs, miscellaneous, for endoscope (FFY) (4) Accessories, Cleaning Brushes, For Endoscope (MNL) (3) BRONCHOSCOPE (FLEXIBLE OR RIGID) (EOQ) (2) Colonoscope and accessories, flexible/rigid (FDF) (1)

Premarket Exempt

No Yes

Clear

FUJIFILM - 04547410079074 Catalog Number :

Device Description : This product is intended to clean the instrument/suction channel and accessories

Device Class :

Duns Number: 713565195

Premarket Exempt : No

Product Code : EOQ

Prescription Use : No

Device Count : 1

FUJIFILM - 04547410079104 Catalog Number :

Device Description : This product is intended to clean the instrument/suction channel and accessories

Device Class :

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

FUJIFILM - 04547410079111 Catalog Number :

Device Description : This product is intended to clean the instrument/suction channel and accessories

Device Class :

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

FUJIFILM - 04547410079128 Catalog Number :

Device Description : This product is intended to clean the instrument/suction channel and accessories

Device Class :

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

FUJIFILM - 04547410079142 Catalog Number :

Device Description : This product is intended to be opened the inner pressure of the endoscope to the

Device Class : 1

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

FUJIFILM - 04547410079159 Catalog Number :

Device Description : This product is used for forward water conveyance to wash digestive tract in dia

Device Class : 2

Duns Number: 713565195

Premarket Exempt : No

Product Code : FDF

Prescription Use : No

Device Count : 1

FUJIFILM - 04547410079166 Catalog Number :

Device Description : This product is intended to attach the balloon to the distal end of FUJIFILM ul

Device Class : 1

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

FUJIFILM - 04547410079173 Catalog Number :

Device Description : This product is intended to install rubber band for balloon in endoscope.

Device Class : 1

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

FUJIFILM - 04547410079180 Catalog Number :

Device Description : This product is intended to install balloon in endoscope.

Device Class :

Duns Number: 713565195

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 20

FUJIFILM - 04547410079197 Catalog Number :

Device Description : This product is intended to inject the reprocessing fluids during manual cleanin

Device Class :

Duns Number: 713565195

Premarket Exempt : No

Product Code : EOQ

Prescription Use : No

Device Count : 1

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