SONTEC INSTRUMENTS, INC.

Address:7248 SOUTH TUCSON WAY,CENTENNIAL,CO,80112,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

Laparoscope, General & Plastic Surgery (GCJ) (8) Catheter And Tip, Suction (JOL) (1) Clamp, Vascular (DXC) (1)

Premarket Exempt

No Yes

Clear

MICTEC LARGE 3 WAY TAP - 00192896000001 Catalog Number : 04-11001-00

Device Description : MICTEC LARGE 3 WAY TAP

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

FLEXIBLE TROCAR SLEEVE - 00192896000018 Catalog Number :

Device Description : FLEXIBLE TROCAR SLEEVE PACKAGE OF 12

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

COOLEY LIGATURE CARRIER CLAMP - 00192896000025 Catalog Number : 2100-212

Device Description : COOLEY LIGATURE CARRIER CLAMP SMALL CURVED SERRATED TIP

Device Class : 1

Duns Number: 040729840

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

FUKUSHIMA SUCTION TUBE - 00192896000032 Catalog Number :

Device Description : FUKUSHIMA SUCTION TUBE

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

THORACIC SUCTION TUBE - 00192896000049 Catalog Number :

Device Description : THORACIC SUCTION TUBE WITH PYNCHON HANDLE ANGLED

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

SONTEC SUCTION TUBE - 00192896000056 Catalog Number :

Device Description : SONTEC SUCTION TUBE WITH FINGER CONTROL

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

MICTEC SUCTION-IRRIGATION TUBE - 00192896000063 Catalog Number :

Device Description : MICTEC SUCTION-IRRIGATION TUBE ROTABLE CURVED

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

MICTEC SUCTION-IRRIGATION TUBE - 00192896000070 Catalog Number :

Device Description : MICTEC SUCTION-IRRIGATION TUBE ROTABLE CURVED

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

MICTEC TALKUM SPRAY GLASS BOTTLE - 00192896000087 Catalog Number :

Device Description : MICTEC TALKUM SPRAY GLASS BOTTLE

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

BELLOW WITH VENTIL AND CONNECTION - 00192896000094 Catalog Number :

Device Description : BELLOW BLUE WITH VENTIL AND CONNECTION M8

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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