VITALITEC INTERNATIONAL, INC.

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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) (9) Clamp, Vascular (DXC) (1)

Premarket Exempt

Yes No

Clear

Vitalitec Graspers - 00850001784504 Catalog Number :

Device Description : Surgical Graspers MI-3020 (Miami Instrument Narrow DeBakey Grasper 30cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Vitalitec Graspers - 00850001784511 Catalog Number :

Device Description : Surgical Graspers MI-3026 (Miami Instrument Wide DeBakey Grasper, Modular Handle Surgical Graspers MI-3026 (Miami Instrument Wide DeBakey Grasper, Modular Handle, Standard Handle)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Vitalitec Surgical Scissors - 00850001784528 Catalog Number :

Device Description : Surgical Scissors MI-3033 (Miami Instruments Robust Scissor,7mm Shaft, Modular H Surgical Scissors MI-3033 (Miami Instruments Robust Scissor,7mm Shaft, Modular Handle, Standard handle)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Vitalitec Knot Pushers - 00850001784535 Catalog Number :

Device Description : Surgical Needle Holder MI-3502 (MI,TC Needle Holder cvd.,Modular Handle, Standar Surgical Needle Holder MI-3502 (MI,TC Needle Holder cvd.,Modular Handle, Standard Handle Insert, 35cm length)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Vitalitec Graspers - 00850001784542 Catalog Number :

Device Description : Surgical Graspers MI-3520 (Miami Instrument Narrow DeBakey Grasper 35cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Vitalitec Graspers - 00850001784559 Catalog Number :

Device Description : Surgical Graspers MI-3526 (Miami Instrument Wide DeBakey Grasper, Modular Handle Surgical Graspers MI-3526 (Miami Instrument Wide DeBakey Grasper, Modular Handle, Standard Handle)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Vitalitec Surgical Scissors - 00850001784566 Catalog Number :

Device Description : Surgical Scissors MI-3533 (Miami Instruments Robust Scissor,7mm Shaft, Modular H Surgical Scissors MI-3533 (Miami Instruments Robust Scissor,7mm Shaft, Modular Handle, Standard handle)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Vitalitec Surgical Scissors - 00850001784573 Catalog Number :

Device Description : Surgical Scissors MI-3561 (Miami Instrument Potts Scissors, Sharp, 45 degree, he Surgical Scissors MI-3561 (Miami Instrument Potts Scissors, Sharp, 45 degree, heavy pattern, 35cm length)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Vitalitec MI Ball Point Probe - 00850001784580 Catalog Number :

Device Description : Surgical Probe

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

InTrack Clamp - 00850001784597 Catalog Number :

Device Description : Reusable, Surgical Vascular Clamp for vessel occlusion

Device Class : 2

Duns Number: 121464288

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

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