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) (10)

Premarket Exempt

No Yes

Clear

Vitalitec Clip Appliers - 00857987006781 Catalog Number :

Device Description : PVC328-E (Med/Large Applier, 28cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006798 Catalog Number :

Device Description : PB215-1B (Medium Applier, 15cm Length - Vitalitec Logo Prt Number PB215-1)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006804 Catalog Number :

Device Description : PB215-E (Medium Clip Applier, 15cm, E Etched)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006811 Catalog Number :

Device Description : PB220-1B (Applier, Medium Clips, 20cm Length - Vitalitec Logo)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006828 Catalog Number :

Device Description : PB220-E (20cm Applier, Medium 9 Clip Cartridge)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006835 Catalog Number :

Device Description : PB228-1B (Medium Clip Applier, 28cm Length Vitalitec Part Number and Logo)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006842 Catalog Number :

Device Description : PB228-E (Medium Clip Applier 28cm blue (E-Model))

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006859 Catalog Number :

Device Description : PB228-EB (Medium Light Applier, FS, 28cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006866 Catalog Number :

Device Description : PBB220-1 (20cm Bayonet Applier for SLS Medium Clips, Vitalitec Supplied Jaws)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006873 Catalog Number :

Device Description : PBB234-1 (Bayonet applier for Medium Clips, 34.1cm length, FSP0337)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

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