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 - 00850001784306 Catalog Number :

Device Description : PR119-E (Small Red Applier, 19cm E Etch)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784313 Catalog Number :

Device Description : PR128-1B (Red Small Applier, 28cm Length, Vitalitec Code and Logo)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784320 Catalog Number :

Device Description : PRB120-1 (20cm Bayonet Applier for SLS Small Red 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 - 00850001784337 Catalog Number :

Device Description : PRB134-1 (Bayonet Applier for Small Clips, 34.1cm Length - DWG FSP0251 from 2/28/12)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784344 Catalog Number :

Device Description : PRB136-1 (36cm Bayonet Applier for SLS Small Red 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 - 00850001784351 Catalog Number :

Device Description : PRC128-1B (Red Small Applier, 28cm Curved, Vitalitec Logo)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784368 Catalog Number :

Device Description : PRC128-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 - 00850001784375 Catalog Number :

Device Description : PRE115-B (15cm 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 - 00850001784382 Catalog Number :

Device Description : PRE119-1B (Small Red 19cm Ethicon Style Applier, One Ring Red, One Ring Black, Vi...

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

Vitalitec Clip Appliers - 00850001784399 Catalog Number :

Device Description : PRE119-E (Small E Style Applier 19cm,Soft spring, Thick)

Device Class : 1

Duns Number: 121464288

Premarket Exempt : Yes

Product Code : HBT

Prescription Use : Yes

Device Count : 1

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