CORK MEDICAL, LLC

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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

Negative Pressure Wound Therapy Powered Suction Pump (OMP) (10)

Premarket Exempt

Yes No

Clear

Nisus NPWT System - 00851675007005 Catalog Number :

Device Description : Negative Pressure Wound Therapy System (battery charger, user manual and patient Negative Pressure Wound Therapy System (battery charger, user manual and patient bag included)

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT Wound Kit - 00851675007012 Catalog Number :

Device Description : Negative Pressure Wound Therapy Dressing, Wound Kit, Medium with 1.2.3 Drape

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT Wound Kit - 00851675007029 Catalog Number :

Device Description : Negative Pressure Wound Therapy Dressing, Wound Kit, Large with 1.2.3 Drape

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT Accessory - 00851675007036 Catalog Number :

Device Description : NPWT 10" x 12" 1.2.3 Drape

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT Accessory - 00851675007043 Catalog Number :

Device Description : NPWT, Peel and Stick Drape

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT Accessory - 00851675007050 Catalog Number :

Device Description : NPWT, Medium Foam

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT Accessory - 00851675007067 Catalog Number :

Device Description : Large Foam

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT Accessory - 00851675007074 Catalog Number :

Device Description : Port Pad Assembly

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT Accessory - 00851675007081 Catalog Number :

Device Description : 24" Tubing Extension

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Nisus NPWT System - 00851675007098 Catalog Number :

Device Description : 250-mL Canister

Device Class : 2

Duns Number: 015964214

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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