OLYMPUS MEDICAL SYSTEMS CORP.

Address:2951 ISHIKAWA-CHO,HACHIOJI-SHI Tokyo,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

Endoscope, accessories, narrow band spectrum (NWB) (6) Gastroscope and accessories, flexible/rigid (FDS) (5) Colonoscope and accessories, flexible/rigid (FDF) (5) Endoscopic video imaging system/component, gastroenterology-urology (FET) (3) Enteroscope and accessories (FDA) (1) duodenoscope and accessories, flexible/rigid (FDT) (1) endoscopic access overtube, gastroenterology-urology (FED) (1)

Premarket Exempt

No Yes

Clear

Foot holder - 04953170022807 Catalog Number :

Device Class :

Duns Number: 711789789

Premarket Exempt : No

Product Code : NWB, FDF, FDS

Prescription Use : Yes

Device Count : 4

Foot holders - 04953170022814 Catalog Number :

Device Description : "MAJ-878 FOOT HOLDER 4PCS FOR CV-160 AND"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

VIDEOSCOPE CABLE HOLDER - 04953170022821 Catalog Number :

Device Description : "MAJ-879 VIDEOSCOPE CABLE HOLDER CV-160"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

SPARE FUSE - 04953170022852 Catalog Number :

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FED, NWB, FDA

Prescription Use : Yes

Device Count : 1

Spare fuse - 04953170022876 Catalog Number :

Device Description : "MAJ-890 SPARE FUSE FOR CV-160"

Device Class :

Duns Number: 711789789

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 2

Water container - 04953170022913 Catalog Number :

Device Description : "MAJ-901 WATER CONTAINER SET CV-160/140"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FDF, NWB, FDS

Prescription Use : Yes

Device Count : 1

WATER CONTAINER - 04953170022937 Catalog Number :

Device Description : "MAJ-902 C02 GAS/WATER CONTAIN CV-160/140"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FDF, FDS, NWB

Prescription Use : Yes

Device Count : 1

CONTAINER PROTECTOR - 04953170022944 Catalog Number :

Device Description : "MAJ-905 WATER CONTAINER PROTECTOR RUBBER"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FDS, NWB, FDF

Prescription Use : Yes

Device Count : 1

ALCOHOL CONTAINER - 04953170022968 Catalog Number :

Device Description : "MB-264 RED DISINFECTANT CONT F/MU-1"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : NWB, FDS, FDF

Prescription Use : Yes

Device Count : 1

FOOT RELEASE - 04953170022975 Catalog Number :

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FDT

Prescription Use : Yes

Device Count : 1

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