STRADIS MEDICAL LLC

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

Blood Specimen Collection Convenience Kit (Excludes Hiv) (PQD) (2) Personal Protection Kit (PXC) (2) Drape, Surgical (KKX) (1) General Purpose Dental Tray (OFX) (1) Set, Administration, Intravascular (FPA) (1)

Premarket Exempt

No Yes

Clear

DiSorb Systems, Inc. - B704DISV1020 Catalog Number :

Device Description : IV STAR KIT

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

IV START KIT - M57257028311 Catalog Number :

Device Description : PREP AREA FOR A NEW OR REPLACEMENT IV

Device Class : 1

Duns Number: 043537671

Premarket Exempt : Yes

Product Code : OFX

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752010563SH0 Catalog Number :

Device Description : Rapid Airway Introducer

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M7521000410 Catalog Number :

Device Description : NIMBUS II START OF CARE KIT

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M75211346851 Catalog Number :

Device Description : Patient Admin Kit

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M75220099SSHP0 Catalog Number :

Device Description : STANDARD HYGIENE PACK

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : PXC

Prescription Use : No

Device Count : 1

Stradis Medical, LLC. - M75220100SSOP0 Catalog Number :

Device Description : STANDARD OPERATIVE PACK

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : PXC

Prescription Use : No

Device Count : 1

Stradis Medical, LLC. - M7525113880 Catalog Number :

Device Description : Universal Kit

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M7525113890 Catalog Number :

Device Description : Pen Needle Kit

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code : PQD

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M7525113900 Catalog Number :

Device Description : Pen Needle Kit

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : PQD

Prescription Use : Yes

Device Count : 1

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