KCI USA, INC.

Address:6203 FARINON DR.,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) (9) Dermatome (GFD) (1)

Premarket Exempt

No Yes

Clear

V.A.C.® - 00849554003323 Catalog Number :

Device Description : V.A.C. DRAPE

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® - 00849554003378 Catalog Number :

Device Description : VAC Y-CONNECTOR

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.® - 00849554003385 Catalog Number :

Device Description : VAC TUBING CAP

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.VIA™ - 00849554003750 Catalog Number :

Device Description : VAC VIA 250ml Canister

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.VIA™ GRANUFOAM™ - 00849554003767 Catalog Number :

Device Description : VAC VIA Dressing Medium Featuring a Granufoam Spiral Dressing

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C.VIA™ GRANUFOAM™ - 00849554003774 Catalog Number :

Device Description : Vac Via Dressing Small

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

CELLUTOME™ - 00849554004078 Catalog Number :

Device Description : Cellutome Harvester Strap Extension

Device Class :

Duns Number: 102726734

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 5

PREVENA™ PEEL & PLACE™ - 00849554004627 Catalog Number :

Device Description : Prevena Peel & Place System Kit- 13 cm

Device Class : 2

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

PREVENA™ PEEL & PLACE™ - 00849554004641 Catalog Number :

Device Description : Prevena Peel & Place Dressing- 13 cm

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

V.A.C. VERAFLO™ - 00849554004733 Catalog Number :

Device Description : Vac Veraflo Cleanse Choice Dressing- Medium

Device Class :

Duns Number: 102726734

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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