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) Device, Intravascular Catheter Securement (KMK) (1) Peripheral Catheter Insertion Kit (OWL) (1)

Premarket Exempt

No Yes

Clear

Stradis Medical, LLC. - M752BRF236MSP18030 Catalog Number :

Device Description : Central Line Dressing Change Tray

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752CD22000 Catalog Number :

Device Description : Dressing Change Kit

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752COTA81361 Catalog Number :

Device Description : Implant Kit

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752COTA81381 Catalog Number :

Device Description : Explant Kit

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752CPD20000 Catalog Number :

Device Description : Catheter Securement Device

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : KMK

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752DC1790920 Catalog Number :

Device Description : PICC / Midline Tray

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : OWL

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752DC5480 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 - M752DC5600 Catalog Number :

Device Description : Dressing Change Tray

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : MCY

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752DC560A0 Catalog Number :

Device Description : Dressing Change Tray

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : MCY

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752DC8903CP20 Catalog Number :

Device Description : Dressing Change Tray

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : MCY

Prescription Use : Yes

Device Count : 1

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