SCANLAN INTERNATIONAL INC

Address:1 SCANLAN PLZ,Saint Paul,MN,55107,US

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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

Scissors, General, Surgical (LRW) (3) Catheter And Tip, Suction (JOL) (1) Clamp, Surgical, General & Plastic Surgery (GDJ) (1) Marker, Cardiopulmonary Bypass (Vein Marker) (MAB) (1) Retractor (GAD) (1)

Premarket Exempt

No Yes

Clear

SCANLAN® Instrumentation - 00846159035858 Catalog Number : CDA002-RS

Device Description : SCANLAN® Retractor Blade

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

SCANLAN® Scissors - 00846159035865 Catalog Number : Q28108-7

Device Description : DeMartel Scissors

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

SCANLAN® Minimally Invasive Instrument - 00846159035889 Catalog Number : COA013-09

Device Description : Suction Instrument

Device Class : 2

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres - 10846159000570 Catalog Number : 1001-542B

Device Description : Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Midi Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Midi Straight (yellow),clamping pressure 75-80 g (1/sterile pkg, 5/box)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® RADIOMARK® graft markers - 10846159001041 Catalog Number : 1001-831

Device Description : Disk-shaped style, silicone (1 per sterile pkg)

Device Class :

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : MAB

Prescription Use : Yes

Device Count : 10

SCANLAN® - 10846159023708 Catalog Number : 1001-3110

Device Description : Biopsy Needle stainless steel 10 mm window

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

SCANLAN® - 10846159023715 Catalog Number : 1001-3115

Device Description : Biopsy Needle stainless steel 5 mm window

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

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