CENTESE, INC.

Address:4156 S 52nd St,Omaha,NE,68117,US

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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

Catheter, Irrigation (GBX) (2) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (2)

Premarket Exempt

No Yes

Clear

Thoraguard - 00860000436403 Catalog Number : TGCT120020

Device Description : Thoraguard Chest Tube Kit, 20 Fr

Device Class : 1

Duns Number: 081331672

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Thoraguard - 00860000436410 Catalog Number : TGDK110012

Device Description : Thoraguard Drainage Kit

Device Class : 2

Duns Number: 081331672

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thoraguard - 00860000436427 Catalog Number : TGCM1000

Device Description : Thoraguard Control Module

Device Class : 2

Duns Number: 081331672

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Thoraguard - 00860000436441 Catalog Number : TGCT120028

Device Description : Thoraguard Chest Tube Kit, 28 Fr

Device Class : 1

Duns Number: 081331672

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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