MOTUS GI MEDICAL TECHNOLOGIES LTD

Address:22 Keren Ha'yesod st.,Tirat Carmel Haifa,IL

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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

Colonoscope And Accessories, Flexible/Rigid (FDF) (10)

Premarket Exempt

Clear

Pure-Vu - 05060513700007 Catalog Number : PV-WS-001

Device Description : (1) Workstation with foot pedal

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700014 Catalog Number : PV-LF-001

Device Description : (1) Loading fixture with sealing plug

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700021 Catalog Number : PV-UF-001

Device Description : (1) Unloading fixture with sealing plug

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700038 Catalog Number : PV-LUFK-001

Device Description : (1) Loading fixture & (1) Unloading fixture with sealing plugs

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700045 Catalog Number : PV-OSK-001

Device Description : (1) Oversleeve

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700052 Catalog Number : PV-OS-001

Device Description : (1) Oversleeve individually packaged

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700069 Catalog Number : PV-WSCK-001

Device Description : (1) Workstation connector

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700076 Catalog Number : PV-WSC-001

Device Description : (1) Workstation connector individually packaged

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700106 Catalog Number : PV-SLMK-001

Device Description : (5) Slim Oversleeves individually packaged

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Pure-Vu - 05060513700120 Catalog Number : PV-SLM-001

Device Description : (1) Slim Oversleeve individually packaged

Device Class : 2

Duns Number: 532775983

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

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