ACCESS SCIENTIFIC, LLC

Address:3910 Sorrento Valley Blvd Ste 200,San Diego,CA,92121,US

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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

Introducer, Catheter (DYB) (6) Peripheral Catheter Insertion Kit (OWL) (2) Catheter, Percutaneous (DQY) (1) Dressing Change Tray (OXQ) (1)

Premarket Exempt

No Yes

Clear

POWERWAND - 00859821006674 Catalog Number : 72627

Device Description : POWERWAND™ ED Quick Kit 3FR 6cm

Device Class :

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL - 00859821006681 Catalog Number : 80701

Device Description : The POWERWAND™ XL Introducer with Extended Dwell Catheter, 4Fr x 10cm

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

ARTERIAL WAND - 00859821006698 Catalog Number : 96001

Device Description : The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB, DQY

Prescription Use : Yes

Device Count : 1

CVC WAND - 00859821006704 Catalog Number : 93001

Device Description : The CVC WAND Safety Introducer with Valved Peelable Sheath

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

CVC WAND XL - 00859821006711 Catalog Number : 93102

Device Description : The CVC WAND Safety Introducer with Valved Peelable Sheath

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

POWERWAND - 00859821006759 Catalog Number : 71752

Device Description : Dressing Change Kit w/Statlock

Device Class : 1

Duns Number: 079290879

Premarket Exempt : Yes

Product Code : OXQ

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL Alternate Site with Needle Guide Kit - 00859821006766 Catalog Number : 80757

Device Description : POWERWAND™ XL Alternate Site with Needle Guide Kit

Device Class : 2

Duns Number: 079290879

Premarket Exempt : Yes

Product Code : OWL

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL Maximum Barrier Kit - 00859821006773 Catalog Number : 94108

Device Description : POWERWAND™ XL Maximum Barrier Kit, 4Fr x 10cm

Device Class :

Duns Number: 079290879

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

POWERWAND - 00859821006780 Catalog Number : 40459

Device Description : POWERWAND™ ED 3Fr x 6cm (Custom)

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

POWERWAND - 00859821006797 Catalog Number : 72641

Device Description : POWERWAND™ ED Quick Kit 3Fr x 6cm (Custom)

Device Class : 2

Duns Number: 079290879

Premarket Exempt : Yes

Product Code : OWL

Prescription Use : Yes

Device Count : 1

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