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

WoundPro Control Unit - 00851978007009 Catalog Number :

Device Description : WoundPro Control Unit, Control Unit Only

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Hydrophilic Foam Dressing, Small - 00851978007054 Catalog Number :

Device Description : Hydrophilic Foam Dressing, Small, 10 per case

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 10

Hydrophilic Foam Dressing, Medium - 00851978007078 Catalog Number :

Device Description : Hydrophilic Foam Dressing, Medium, Case of 10

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 10

WoundPro Uniflo Advanced Y Connector - 00851978007092 Catalog Number :

Device Description : WoundPro Uniflo Advanced Y Connector, Each

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

MicroDoc Mini Stingray and Drape Set - 00851978007146 Catalog Number :

Device Description : MicroDoc Mini Stingray and Drape Set, Each

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Basic Series Combo Pack, Small - 00851978007313 Catalog Number :

Device Description : Basic Series Small Combo Pack (12 ea 0583 kits;4 ea 0222 canisters)

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Basic Series Combo Pack, Medium - 00851978007320 Catalog Number :

Device Description : Basic Medium Combo Pack (12 ea 0584 kits; 4 ea 0222 canisters)

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Basic Series Combo Pack, Large - 00851978007337 Catalog Number :

Device Description : Basic Series Large Combo Pack (12 ea 0585 kits; 4 ea 0222 canisters)

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Advanced Series Combo Pack, Small - 00851978007344 Catalog Number :

Device Description : Advanced Series Small Combo Pack (12ea 0731 kits; 4 ea 0734 canisters)

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Advanced Series Combo Pack, Medium - 00851978007351 Catalog Number :

Device Description : Advanced Series Medium Combo Pack (12ea 0732 kits; 4 ea 0734 canisters)

Device Class : 2

Duns Number: 079262228

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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