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

Applier, Hemostatic Clip (HBT) (7) Clamp, Vascular (DXC) (3)

Premarket Exempt

No Yes

Clear

InTrack Clamp - 00857987006385 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

InTrack Clamp - 00857987006392 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

InTrack Clamp - 00857987006408 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

Vitalitec Clip Appliers - 00857987006415 Catalog Number :

Device Description : Vitalitec Clip Appliers LCA-0515M (5mm, 15cm Lap Applier for Micro Clips)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006422 Catalog Number :

Device Description : LCA-1033 L (33 cm Lap Applier for Large Clips)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006439 Catalog Number :

Device Description : LCA-1033 M (33 cm Lap Applier for Medium Clips, Edlo # 14-1487)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006446 Catalog Number :

Device Description : LCA-1033 M/L (33 cm Lap Applier for Med/Lrg. Clips)LCA-10mmIn (Medium Lap Insert Only)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006453 Catalog Number :

Device Description : LCA SLS5/45 (Lap Applier, Med/Large Clips - 45cm Length)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006460 Catalog Number :

Device Description : LCA SLS5/47 (Lap Applier, Med/Large Clips - 45cm Length)LCA1033ML INS (ML INSERT ONLY)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006477 Catalog Number :

Device Description : LCA-10mm (Lap Appliers - 10mm - Take apart) - Other

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

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