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) (5)

Premarket Exempt

Clear

ReTAP® Cardiovascular Patch - B042FG0008211 Catalog Number : FG0008-21

Device Description : 6mm ID x 5cm 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 - B042FG0008221 Catalog Number : FG0008-22

Device Description : 7mm ID x 5cm 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 - B042FG0008231 Catalog Number : FG0008-23

Device Description : 8mm ID x 5cm 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 - B042FG0008241 Catalog Number : FG0008-24

Device Description : 9mm ID x 5cm 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 - B042FG0008251 Catalog Number : FG0008-25

Device Description : 10mm ID x 5cm 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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