OAKWELL DISTRIBUTION, INC.

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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)

Premarket Exempt

Clear

extriCARE - 00879766005778 Catalog Number :

Device Description : NPWT Bandage-Incision management with tubing set

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005792 Catalog Number :

Device Description : 7 pieces of silicone gel strip

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005822 Catalog Number :

Device Description : NPWT Foam kit-large

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005839 Catalog Number :

Device Description : NPWT Foam kit-samll

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

extriCARE - 00879766005846 Catalog Number :

Device Description : 1 piece of Extra Skin Film

Device Class : 2

Duns Number: 033337813

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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