KCI USA, INC.

Address:12930 IH 10 West,San Antonio,TX,78249,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

Negative Pressure Wound Therapy Powered Suction Pump (OMP) (5) Dermatome (GFD) (3) Mesh, Surgical, Polymeric (FTL) (2)

Premarket Exempt

No Yes

Clear

V.A.C. WHITEFOAM™ - 00849554000803 Catalog Number :

Device Description : VAC Whitefoam Dressing Small Featuring Sensatrac Technology

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. WHITEFOAM™ - 00849554000810 Catalog Number :

Device Description : VAC Whitefoam Dressing Large Featuring Sensatrac Technology

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. WHITEFOAM™ - 00849554000827 Catalog Number :

Device Description : VAC Whitefoam Dressing Large Featuring Sensatrac Technology

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.ULTA™ - 00849554001084 Catalog Number :

Device Description : VAC ULTA THERAPY SYSTEM

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

CELLUTOME™ - 00849554001176 Catalog Number :

Device Description : Cellutome Epidermal Harvesting System Control Unit Stand

Device Class : 1

Duns Number: 102726734

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

CELLUTOME™ - 00849554001213 Catalog Number :

Device Description : Cellutome Epidermal Harvesting System Harvester (2.5cm)

Device Class :

Duns Number: 102726734

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

CELLUTOME™ - 00849554001220 Catalog Number :

Device Description : Cellutome Epidermal Harvesting System Harvester (5.0cm)

Device Class :

Duns Number: 102726734

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

ABTHERA™ - 00849554001268 Catalog Number :

Device Description : Abthera Open Abdomen Dressing

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

ABTHERA™ - 00849554001275 Catalog Number :

Device Description : Abthera Tubing Set

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

ABTHERA™ SENSAT.R.A.C.™ - 00849554001282 Catalog Number :

Device Description : Abthera Open Abdomen Dressing with Sensatrac pad

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

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