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) (5) Laparoscope, General & Plastic Surgery (GCJ) (2) Catheter And Tip, Suction (JOL) (1) Instrument, Ligature Passing And Knot Tying (HCF) (1) Instrument, Surgical, Disposable (KDC) (1)

Premarket Exempt

No Yes

Clear

SCANLAN® - 00846159000443 Catalog Number : 9909-910SC

Device Description : Super Cut™ Metzenbaum Scissors

Device Class : 2

Duns Number: 023055619

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

SCANLAN® Knot Pusher - 00846159000450 Catalog Number : 9009-828

Device Description : CardioVasive™ Chitwood Knot Tier/Pusher

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : HCF

Prescription Use : Yes

Device Count : 1

SCANLAN® - 00846159000467 Catalog Number : 9009-280

Device Description : Thoracoscopic Adson Foceps

Device Class : 2

Duns Number: 023055619

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

SCANLAN® Suction System Devices - 00846159000474 Catalog Number : 9009-900

Device Description : Thoracoscopic Wolf Suction Instrument

Device Class : 2

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

SCANLAN® Ultimate® A/V Punch - 00846159000481 Catalog Number : 1001-609

Device Description : SCANLAN® Ultimate® A/V Punch, 4.0 x 2.0 mm (Elliptical)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® single-use bulldog clamp - 00846159000498 Catalog Number : 1001-499

Device Description : Scanlan® VASCU-STATT® single-use bulldog clamp - Micro Straight (purple), clampi Scanlan® VASCU-STATT® single-use bulldog clamp - Micro Straight (purple), clamping pressure 15-20 gr (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 single-use bulldog clamp w/firmer clamping press - 00846159000504 Catalog Number : 1001-529

Device Description : Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Micr Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Micro Straight (black), clamping pressure 30-40 gr (2/sterile pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Scanlan® VASCU-STATT® approximator single-use bulldog clamp - 00846159000528 Catalog Number : 1001-509

Device Description : Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Straight (whi Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Straight (white), clamping pressure 25-30 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® approximator single-use bulldog clamp - 00846159000535 Catalog Number : 1001-510

Device Description : Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Angled 45° (w Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Angled 45° (white), clamping pressure 25-30 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® approximator single-use bulldog clamp - 00846159000542 Catalog Number : 1001-511

Device Description : Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Straight (blu Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Straight (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

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