EXIMO MEDICAL LTD

Address:Pekeris St. 3,Rehovot Central,IL

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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

Catheter, Peripheral, Atherectomy (MCW) (10)

Premarket Exempt

Clear

1.5 mm OTW B-Laser™ catheter - 07290017590004 Catalog Number :

Device Description : 1.5 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : No

Device Count : 1

0.9 mm OTW B-Laser™ catheter - 07290017590011 Catalog Number :

Device Description : 0.9 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : No

Device Count : 1

2.0 mm OTW B-Laser™ catheter - 07290017590028 Catalog Number :

Device Description : 2.0 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : No

Device Count : 1

2.35 mm OTW B-Laser™ catheter - 07290017590035 Catalog Number :

Device Description : 2.35 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : No

Device Count : 1

Laser system - 07290017590042 Catalog Number :

Device Description : 200-240 Vac Laser system For Infra Inguinal Atherectomy

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : No

Device Count : 1

Laser system - 07290017590059 Catalog Number :

Device Description : 100-120 Vac Laser system For Infra Inguinal Atherectomy

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : No

Device Count : 1

Auryon Atherectomy Catheter 1.5 mm OTW - 07290017590066 Catalog Number : EXM-4001-0000

Device Description : Auryon Atherectomy Catheter 1.5 mm OTW

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Auryon Atherectomy Catheter 0.9 mm OTW - 07290017590073 Catalog Number : EXM-4002-0000

Device Description : Auryon Atherectomy Catheter 0.9 mm OTW

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Auryon Atherectomy Catheter 2.0 mm OTW - 07290017590080 Catalog Number : EXM-4003-0000

Device Description : Auryon Atherectomy Catheter 2.0 mm OTW

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Auryon Atherectomy Catheter 2.35 mm OTW - 07290017590097 Catalog Number : EXM-4004-0000

Device Description : Auryon Atherectomy Catheter 2.35 mm OTW

Device Class : 2

Duns Number: 600468941

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

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