Pensar Medical, LLC

Address:684 Parkridge Ave.,Norco,CA,92860,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) (10)

Premarket Exempt

No Yes

Clear

Advanced Series Combo Pack, Large - 00851978007368 Catalog Number :

Device Description : Advanced Series Large Combo Pack (12ea 0733 kits; 4 ea 0734 canisters)

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

WoundPro Power Supply Cord - 00851978007436 Catalog Number :

Device Description : WoundPro Power Supply Cord, Each

Device Class : 2

Duns Number: 079262228

Premarket Exempt : Yes

Product Code : OMP

Prescription Use : No

Device Count : 1

WoundPro Carrying Case - 00851978007443 Catalog Number :

Device Description : WoundPro Carrying Case

Device Class : 2

Duns Number: 079262228

Premarket Exempt : Yes

Product Code : OMP

Prescription Use : No

Device Count : 1

WoundPro EZ Clasp Mounting Bracket - 00851978007450 Catalog Number :

Device Description : Mounting Bracket for WoundPro Control Unit

Device Class : 2

Duns Number: 079262228

Premarket Exempt : Yes

Product Code : OMP

Prescription Use : Yes

Device Count : 1

MicroDoc NPWT Control Unit - 00851978007467 Catalog Number :

Device Description : MicroDoc NPWT Control Unit, Only

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

WoundPro Collection Canister - 10851978007013 Catalog Number :

Device Description : WoundPro 300cc Collection Canister with 5 foot tubing, Case of 16

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 16

WoundPro 300cc Basic Canister w/8' Tubing - 10851978007020 Catalog Number :

Device Description : WoundPro 300cc Basic Canister w/8' Tubing, 16 per case

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 16

WoundPro Collection Canister - 10851978007037 Catalog Number :

Device Description : WoundPro 800cc Collection Canister, Case of 16

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 16

WoundPro UniFlow Connector - 10851978007082 Catalog Number :

Device Description : WoundPro UniFlow Y Connector Case of 10

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 10

ProFoam Bridge Dressing - 10851978007105 Catalog Number :

Device Description : ProFoam Bridge Dressing, Case of 10 pairs (2 per package)

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 10

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