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) Central Venous Catheter Tray (OFF) (1) Container, Liquid Medication, Graduated (KYW) (1) Media,Coupling,Ultrasound (MUI) (1)

Premarket Exempt

No Yes

Clear

Stradis Medical, LLC. - M752HCT8275CPB0 Catalog Number :

Device Description : Dressing Change Kit W/CHG

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : MCY

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752HCT8428CP20 Catalog Number :

Device Description : MAX BARRIER PICC INSERTION TRAY

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : OFF

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752HCT847320 Catalog Number :

Device Description : Dressing Change Tray

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752HCT8874VA20 Catalog Number :

Device Description : VAD ACCESS KIT

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752HCT900AGD10 Catalog Number :

Device Description : Arterial line Dressing Change Kit - GUARDIVA 4MM

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : PEZ

Prescription Use : Yes

Device Count : 1

ARTERIAL LINE DRESSING CHANGE KIT - M752HCT900CHX0 Catalog Number :

Device Description : PREP INF DOSE NEW OR REPLACEMENT DRESSING AND FLUSING OF LINE

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : PEZ

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752HCT984910 Catalog Number :

Device Description : Ultrasound Procedure Kit

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : MUI

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752HCT9948BP10 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. - M752HCT9948BP1VG0 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. - M752HCTBBD1001 Catalog Number :

Device Description : SYRINGE CAPS

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : KYW

Prescription Use : Yes

Device Count : 100

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