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) (8) Dermatome (GFD) (1) Mesh, Surgical, Polymeric (FTL) (1)

Premarket Exempt

No Yes

Clear

V.A.C.® GRANUFOAM™ - 00849554002548 Catalog Number :

Device Description : Vac Granufoam Hand Dressing Featuring Sensatrac Technology

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® GRANUFOAM™ - 00849554002555 Catalog Number :

Device Description : Vac Granufoam Dressing X-Large Featuring Sensatrac Technology

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® - 00849554002562 Catalog Number :

Device Description : Vac Abdominal Dressing Featuring Sensatrac Technology

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

V.A.C.® GRANUFOAM™ - 00849554002579 Catalog Number :

Device Description : SENSATRAC, HEEL DRESSING/POUCH

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

CELLUTOME™ - 00849554002968 Catalog Number :

Device Description : Cellutome Epidermal Harvesting System Control Unit and Vacuum Head

Device Class :

Duns Number: 102726734

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

V.A.C. SIMPLICITY™ - 00849554003071 Catalog Number :

Device Description : VAC Simplicity Negative Pressure Wound Therapy Unit

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. SIMPLICITY™ - 00849554003088 Catalog Number :

Device Description : VAC Simplicity Negative Pressure Wound Therapy Unit

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.VIA™ - 00849554003156 Catalog Number :

Device Description : VAC Via System Starter Kit

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. WHITEFOAM™ - 00849554003279 Catalog Number :

Device Description : VAC Whitefoam Dressing Large

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® - 00849554003286 Catalog Number :

Device Description : VAC Whitefoam dressing Small Foam Only

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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