SOLINAS MEDICAL INC.

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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

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (DXZ) (10)

Premarket Exempt

Clear

ReTAP(TM) Cardiovascular Patch - B042FG0005011 Catalog Number : FG0005-01

Device Description : 6mm ID x 4.5cm length x 230 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP(TM) Cardiovascular Patch - B042FG0005031 Catalog Number : FG0005-03

Device Description : 7mm ID x 4.5cm length x 230 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP(TM) Cardiovascular Patch - B042FG0005051 Catalog Number : FG0005-05

Device Description : 8mm ID x 4.5cm length x 230 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP(TM) Cardiovascular Patch - B042FG0005071 Catalog Number : FG0005-07

Device Description : 9mm ID x 4.5cm length x 230 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP(TM) Cardiovascular Patch - B042FG0005091 Catalog Number : FG0005-09

Device Description : 10mm ID x 4.5cm length x 230 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP® Cardiovascular Patch - B042FG0008021 Catalog Number : FG0008-02

Device Description : 6mm ID x 6cm length x 210 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP® Cardiovascular Patch - B042FG0008041 Catalog Number : FG0008-04

Device Description : 7mm ID x 6cm length x 210 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP® Cardiovascular Patch - B042FG0008061 Catalog Number : FG0008-06

Device Description : 8mm ID x 6cm length x 210 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP® Cardiovascular Patch - B042FG0008081 Catalog Number : FG0008-08

Device Description : 9mm ID x 6cm length x 210 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

ReTAP® Cardiovascular Patch - B042FG0008101 Catalog Number : FG0008-10

Device Description : 10mm ID x 6cm length x 210 degrees

Device Class : 2

Duns Number: 962898792

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

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