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 - 00857987006583 Catalog Number :

Device Description : LCA-5mm (Lap Appliers - 5mm) - Other

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006590 Catalog Number :

Device Description : PO419-B (Large Clip Applier, 19cm

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006606 Catalog Number :

Device Description : PO419-E (Large Clip Applier, 19cm (E-Model))

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006613 Catalog Number :

Device Description : PO420-1B (Large 20cm applier)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006620 Catalog Number :

Device Description : PO420-E (Large Applier 20cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006637 Catalog Number :

Device Description : PO428-1B (Applier-Large Clips- 28cm Length, Vitalitec Logo and Prt NR. PO428-1)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006644 Catalog Number :

Device Description : PO428-E (Large Clip Applier, 28cm E Etched)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006651 Catalog Number :

Device Description : POC419-1 (Large Applier, 19cm Angled)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006668 Catalog Number :

Device Description : POC419-1B (large 19cm Applier, Angled, Vitalitec Logo and part Number)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00857987006675 Catalog Number :

Device Description : POC420-E (Large C Applier, 20cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

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