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 - 00850001784207 Catalog Number :

Device Description : PJ128-1B (Applier for Small Clips, 28cm length)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784214 Catalog Number :

Device Description : PJ128-E (Applier Small Yellow, 28cm E Etch)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784221 Catalog Number :

Device Description : PJ128-EB (Small Style Applier, FS 28cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784238 Catalog Number :

Device Description : PJC128-1 (Small Clip Applier, 28cm Length Angled)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784245 Catalog Number :

Device Description : PJC128-EB (Small Light C Applier FS 28cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784252 Catalog Number :

Device Description : PJE119-1B (Applier, Yellow, 19cm Length, Ethicon Style, One Ring Yellow)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784269 Catalog Number :

Device Description : PJH115-1 (Applier, Small:Half Curved; 15cm)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784276 Catalog Number :

Device Description : PJT120-1B (Lite YELLOW Small applier, Soft Spring, 20cm Length 18deg Angle, VITAL...

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784283 Catalog Number :

Device Description : PR115-1B (15cm Small Clip Applier for Red Clips)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784290 Catalog Number :

Device Description : PR115-E (Small Red Applier, 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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