MEDINOL LTD.

Address:KIRYAT ATIDIM, BLDG. 8,TEL-AVIV Tel Aviv,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

Catheter, Biliary, Diagnostic (FGE) (8) Stent, Coronary (MAF) (2)

Premarket Exempt

Clear

X-SUIT NIR BILIARY METALLIC STENT - 04953170270642 Catalog Number :

Device Class : 2

Duns Number: 600593800

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

X-SUIT NIR BILIARY METALLIC STENT - 04953170270659 Catalog Number :

Device Class : 2

Duns Number: 600593800

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

X-SUIT NIR BILIARY METALLIC STENT - 04953170270666 Catalog Number :

Device Class : 2

Duns Number: 600593800

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

X-SUIT NIR BILIARY METALLIC STENT - 04953170270673 Catalog Number :

Device Class : 2

Duns Number: 600593800

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

X-SUIT NIR BILIARY METALLIC STENT - 04953170270680 Catalog Number :

Device Class : 2

Duns Number: 600593800

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

X-SUIT NIR BILIARY METALLIC STENT - 04953170270697 Catalog Number :

Device Class : 2

Duns Number: 600593800

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

X-SUIT NIR BILIARY METALLIC STENT - 04953170270703 Catalog Number :

Device Class : 2

Duns Number: 600593800

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

X-SUIT NIR BILIARY METALLIC STENT - 04953170270710 Catalog Number :

Device Class : 2

Duns Number: 600593800

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

NIRxcell™ CoCr Coronary Stent on RX System - 07290107010757 Catalog Number :

Device Class : 3

Duns Number: 600593800

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

NIRxcell CoCr Coronary Stent on RX System - 07290107010764 Catalog Number :

Device Class : 3

Duns Number: 600593800

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

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