Alliant Enterprises, LLC

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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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (6) Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (1) Blade, Saw, General & Plastic Surgery, Surgical (GFA) (1) Carrier, Ligature (GEJ) (1) Clamp, Surgical, General & Plastic Surgery (GDJ) (1)

Premarket Exempt

No Yes

Clear

Surge Cardiovascular - 00817278010132 Catalog Number : 213-0251

Device Description : Vein Graft Cannula, Blunt Tip, free-flow

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010149 Catalog Number : 213-026

Device Description : Vein graft cannula, blunt tip with check valve

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010897 Catalog Number : PER-1407S-C02

Device Description : Multiple Perfusion Set (PER-1400S), 15" length w/three free-flow cannulae

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010903 Catalog Number : PER-1401S-C05

Device Description : Multiple Perfusion Set with Vent Line, 15" length, color-coded clamps

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010989 Catalog Number : 213-013NS

Device Description : Suture Guide, 3 pack, Non-Sterile

Device Class : 1

Duns Number: 121170653

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278011269 Catalog Number : SSD-100A

Device Description : Suction Safety Device, Non-Sterile

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278011276 Catalog Number : SUC-4300

Device Description : Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length, non-sterile

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278011306 Catalog Number : TOU-7904

Device Description : Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile

Device Class : 1

Duns Number: 121170653

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278011696 Catalog Number : 5756NS

Device Description : Sarns Sternal Saw II Blades, Non-Sterile

Device Class : 1

Duns Number: 121170653

Premarket Exempt : No

Product Code : GFA

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278011757 Catalog Number : SUC-0840

Device Description : Cardiac Sucker, flexible, fluted tip, 1/4" connector, 14.5" length, non-sterile

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

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