SCANLAN INTERNATIONAL INC

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

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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

Clamp, Surgical, General & Plastic Surgery (GDJ) (10)

Premarket Exempt

No Yes

Clear

Scanlan® VASCU-STATT® approximator single-use bulldog clamp - 00846159000559 Catalog Number : 1001-512

Device Description : Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Angled 45° (b Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Angled 45° (blue), clamping pressure 50-60 g (1/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - 00846159000566 Catalog Number : 1001-535

Device Description : Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Maxi Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Maxi Angled 45°(orange), clamping pressure 165-175 g (2/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres - 00846159000573 Catalog Number : 1001-542

Device Description : Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres - Mi Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres - 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® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres - 00846159000580 Catalog Number : 1001-543

Device Description : Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Mid Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Midi Angled 45° (yellow), clamping pressure 75-80 g (1/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres - 00846159000597 Catalog Number : 1001-544

Device Description : Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Max Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Maxi Straight (orange), clamping pressure 165-175 g (1/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres - 00846159000603 Catalog Number : 1001-545

Device Description : Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Max Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Maxi Angled 45°(orange), clamping pressure 165-175 g (1/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface - 00846159000610 Catalog Number : 1001-550

Device Description : Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface- Midi Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface- Midi Straight (white), clamping pressure 25-30g (2/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface - 00846159000627 Catalog Number : 1001-551

Device Description : Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface- Midi Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface- Midi Angled 45° (white), clamping pressure 25-30g (2/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface - 00846159000634 Catalog Number : 1001-553

Device Description : Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface- Mini Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface- Mini Angled 45° (red), clamping pressure 10-15g (2/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface - 00846159000641 Catalog Number : 1001-552

Device Description : Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface- Mini Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface- Mini Straight (red), clamping pressure 10-15g (2/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

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