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 - 00850001784009 Catalog Number :

Device Description : GEM720-SF (Superfine Micro Applier,20cm Length, GEM Logo and Label)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784016 Catalog Number :

Device Description : MAW 619/22-W (In-Line applier for Micro Clip, working Length 22cm

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784023 Catalog Number :

Device Description : PW 615-1B (Micro Applier, 15cm length)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784030 Catalog Number :

Device Description : PW615-1B (Micro Light Applier, 15cm Length)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784047 Catalog Number :

Device Description : PW615-E (Micro Applier, 15cm E-Etch)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784054 Catalog Number :

Device Description : PW620-1B (Micro Applier, 20cm Length, Vitalitec Logo and WHITE Ring Handles)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784061 Catalog Number :

Device Description : PWB615-1 (Micro Applier, Bayonet Style)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784078 Catalog Number :

Device Description : PWT620-1B (Micro T Style applier, 20cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784085 Catalog Number :

Device Description : MAW 119/22-R (In-Line applier for Small RED clip, working length 22cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784092 Catalog Number :

Device Description : PL515-E (Applier Small Lilac , 15cm E Etch)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

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