STRADIS MEDICAL LLC

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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

Wound Dressing Kit (MCY) (3) Central Venous Catheter Dressing Change Kit (PEZ) (2) Container, I.V. (KPE) (1)

Premarket Exempt

No Yes

Clear

Stradis Medical, LLC - M752HCT100GD20 Catalog Number :

Device Description : CENTRAL LINE KIT 4MM

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : PEZ

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752HCT105002 Catalog Number :

Device Description : 500mL EVA Bags, 2 Port

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 10

Stradis Medical, LLC - M752HCT10CCLL0 Catalog Number :

Device Description : 10CC LUER LOCK SYRINGES

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752HCT1212SB0 Catalog Number :

Device Description : Dressing Change Tray W/ Biopatch

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : MCY

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752HCT1313B0 Catalog Number :

Device Description : Dressing Port Kit W/ Biopatch

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : MCY

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752HCT1CCLL0 Catalog Number :

Device Description : 1CC LUER LOCK SYRINGES

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752HCT1CCSFST0 Catalog Number :

Device Description : 1CC SLIP TIP SYRINGES SILICON FREE

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752HCT1CCST0 Catalog Number :

Device Description : 1CC SLIP TIP SYRINGES

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752HCT200GD20 Catalog Number :

Device Description : DIALYSIS/CORDIS DRESSING CHANGE KIT-GUARDIVA

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : PEZ

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752HCT200GDBP0 Catalog Number :

Device Description : DIALYSIS/CORDIS DRESSING CHANGE KIT BIOPATCH

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : MCY

Prescription Use : Yes

Device Count : 1

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