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

Instruments, Surgical, Cardiovascular (DWS) (6) Laparoscope, General & Plastic Surgery (GCJ) (2) Clamp, Vascular (DXC) (1) Retractor (GAD) (1)

Premarket Exempt

No Yes

Clear

SCANLAN® John Ross Tunneler - 00846159035698 Catalog Number : 9009-32

Device Description : SCANLAN® John Ross A/V Access Tunneler, Full Curve

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SCANLAN® John Ross Tunneler System - 00846159035704 Catalog Number : 9009-34

Device Description : SCANLAN® John Ross Tunneler System, 6mm

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SCANLAN® John Ross Tunneler System - 00846159035711 Catalog Number : 9009-35

Device Description : SCANLAN® John Ross Tunneler System, 7mm Sheaths

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SCANLAN® John Ross Tunneler System - 00846159035728 Catalog Number : 9009-36

Device Description : SCANLAN® John Ross Tunneler System, 8mm Sheaths

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SCANLAN® John Ross Tunneler System - 00846159035735 Catalog Number : 9009-37

Device Description : SCANLAN® John Ross Tunneler System, 9mm Sheaths

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SCANLAN® John Ross Tunneler System - 00846159035742 Catalog Number : 9009-38

Device Description : SCANLAN® John Ross Tunneler System, 10mm Sheaths

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SCANLAN® Thoracoscopic - 00846159035759 Catalog Number : 9209-220

Device Description : SCANLAN® Brigid™ Mini Foerster Clamp, curved 10cm working length

Device Class : 2

Duns Number: 023055619

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

SCANLAN® Clamp - 00846159035780 Catalog Number : Q32006-3

Device Description : Lambert-Kay style clamp

Device Class : 2

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SCANLAN® Minimally-Invasive Instrumentation - 00846159035803 Catalog Number : 9009-241-02

Device Description : SCANLAN® Thoracoscopic DeBakey Clamp, Curved Jaws

Device Class : 2

Duns Number: 023055619

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

SCANLAN® Instrumentation - 00846159035841 Catalog Number : CDA002-LS

Device Description : SCANLAN® Retractor Blade

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

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