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

Peripheral Catheter Insertion Kit (OWL) (2) Blood Specimen Collection Convenience Kit (Excludes Hiv) (PQD) (1) Central Venous Catheter Tray (OFF) (1) General Purpose Dental Tray (OFX) (1) Oral Surgery Tray (PWL) (1)

Premarket Exempt

No Yes

Clear

Stradis Medical, LLC. - M75251910 Catalog Number :

Device Description : PRP CUP KIT

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : OFF

Prescription Use : Yes

Device Count : 1

PATIENT PACK NSU V2 - M75257029021 Catalog Number :

Device Description : HENRY SCHEIN DENTAL TRAINING FOR DENTAL SURGURY. THIS PACK CONTAINS PATIENT PPE HENRY SCHEIN DENTAL TRAINING FOR DENTAL SURGURY. THIS PACK CONTAINS PATIENT PPE USED IN SUPPORT OF ORAL SURGERY. HENRY SCHEIN PRODUCT FOR NSU.

Device Class :

Duns Number: 043537671

Premarket Exempt : Yes

Product Code : PWL

Prescription Use : No

Device Count : 1

DENTAL PACK - M75257029411 Catalog Number :

Device Description : DENTAL TRAINING PACK

Device Class : 1

Duns Number: 043537671

Premarket Exempt : Yes

Product Code : OFX

Prescription Use : Yes

Device Count : 1

FERTILITY HCG IM KIT - M752777778888040 Catalog Number :

Device Description : HOME CONVENIENCE KIT FOR REDUCING MENOPAUSE SYMPTOMS

Device Class :

Duns Number: 043537671

Premarket Exempt : Yes

Product Code : PQD

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M7529992814671 Catalog Number :

Device Description : ANA Kit

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC - M752A10011 Catalog Number :

Device Description : EAR CANAL IRRIGATION KIT

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Stradis Medical, LLC. - M752ACC2500NG0 Catalog Number :

Device Description : PICC Line Insertion Tray

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : OWL

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752ACC2550NG0 Catalog Number :

Device Description : PICC KIT

Device Class : 2

Duns Number: 043537671

Premarket Exempt : No

Product Code : OWL

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752ACC26001 Catalog Number :

Device Description : MAX BARRIER PICC TRAY

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Stradis Medical, LLC. - M752BRF060MSP201DC0 Catalog Number :

Device Description : DRESSING CHANGE KIT (3mL) W/RED BAG

Device Class :

Duns Number: 043537671

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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