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

Laparoscope, General & Plastic Surgery (GCJ) (3) Snare, Surgical (GAE) (2) Forceps, General & Plastic Surgery (GEN) (1) Catheter And Tip, Suction (JOL) (1) Marker, Skin (FZZ) (1) Instruments, Surgical, Cardiovascular (DWS) (1) Clamp, Vascular (DXC) (1)

Premarket Exempt

No Yes

Clear

Scanlan® SURG-I-LOOP® silicone loops - 00846159000306 Catalog Number : 1001-82

Device Description : Scanlan® SURG-I-LOOP® silicone loops - White Maxi, 2.5x1.02 mm, 16"/40 cm long (2/pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GAE

Prescription Use : Yes

Device Count : 1

Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle - 00846159000313 Catalog Number : 1001-82P

Device Description : Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle - Light Orange, 37cm long, nee Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle - Light Orange, 37cm long, needle 1mm diam (2/pkg)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GAE

Prescription Use : Yes

Device Count : 1

SCANLAN® Surgical skin markers - 00846159000368 Catalog Number : 1001-710

Device Description : SCANLAN® Surgical skin markers - Regular Tip, Gentian Violet (1 per sterile pac SCANLAN® Surgical skin markers - Regular Tip, Gentian Violet (1 per sterile package with ruler)

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : Yes

Device Count : 1

SCANLAN® - 00846159000375 Catalog Number : 3003-610

Device Description : Micro Clamp

Device Class : 2

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SCANLAN® Chest Tube Passer - 00846159000382 Catalog Number : 4004-186

Device Description : Scanlan Stern Chest Tube Passer, with ratchet, 9-3/4" / 24.2 cm

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SCANLAN® Forceps - 00846159000399 Catalog Number : 4004-266

Device Description : DeBak Mic NP Fcp, ltwt RH, 2mm carb-inlay tips, 7-1/4" / 18.5 cm

Device Class : 1

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

SCANLAN® Thora Foerster Clp Custom - 00846159000405 Catalog Number : Q31100-9

Device Description : Thora Foerster Clp (7mm) Crvd Lft 12mm Oval Ring Jaws 20cm WL 12"/30.5cm

Device Class : 2

Duns Number: 023055619

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

SCANLAN® Minimally-Invasive Instrumentation - 00846159000412 Catalog Number : 9909-221

Device Description : Thoracoscopic DeBakey Clamp, 10 mm, ring handle, 1x2 curved left taper jaw, 14 1 Thoracoscopic DeBakey Clamp, 10 mm, ring handle, 1x2 curved left taper jaw, 14 1/4" / 36 cm

Device Class : 2

Duns Number: 023055619

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

SCANLAN® Minimally-Invasive Instrumentation - 00846159000429 Catalog Number : 9909-224

Device Description : Thoracoscopic Harken #1 Clamp, 10 mm, ring handle, 1 x 2 DeBakey straight tapere Thoracoscopic Harken #1 Clamp, 10 mm, ring handle, 1 x 2 DeBakey straight tapered jaws, 14.75" / 37.5 cm

Device Class : 2

Duns Number: 023055619

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

SCANLAN® - 00846159000436 Catalog Number : 9909-612

Device Description : Thoracoscopic Needle Holder

Device Class : 2

Duns Number: 023055619

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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