ACCESS SCIENTIFIC, LLC

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

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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) (7) Peripheral Catheter Insertion Kit (OWL) (3)

Premarket Exempt

No Yes

Clear

POWERWAND - 10859821006091 Catalog Number : 92013

Device Description : The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and I The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

POWERWAND XL - 10859821006107 Catalog Number : 94122

Device Description : The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZE The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

CVC WAND - 10859821006114 Catalog Number : 93001

Device Description : The CVC WAND Safety Introducer with Valved Peelabel Sheath and Integral Needle Protection

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

CVC WAND XL - 10859821006121 Catalog Number : 93102

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

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PICC WAND - 10859821006138 Catalog Number : 91010

Device Description : The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PICC WAND - 10859821006145 Catalog Number : 91008

Device Description : The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PICC WAND - 10859821006152 Catalog Number : 91012

Device Description : The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL - 10859821006169 Catalog Number : 94104

Device Description : Quick Kit 4Fr X 8cm

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : OWL

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL - 10859821006176 Catalog Number : 94106

Device Description : POWERWAND™ XL Max Barrier Kit 4Fr X 8cm

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : OWL

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL - 10859821006183 Catalog Number : 80700

Device Description : POWERWAND™ XL Alt Site Kit 4Fr X 8cm

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : OWL

Prescription Use : Yes

Device Count : 1

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