Solo-Dex, Inc

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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

Needle, Conduction, Anesthetic (W/Wo Introducer) (BSP) (5)

Premarket Exempt

Clear

Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit - 08500019130009 Catalog Number :

Device Description : Mini-Kit, 70mm w/ filter

Device Class : 2

Duns Number: 118663297

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Fascile Continuous Peripheral Nerve Block Set - B372500001011 Catalog Number : 500001-01

Device Description : Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a

Device Class :

Duns Number: 118663297

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Fascile Continuous Peripheral Nerve Block Set - B372500001021 Catalog Number : 500001-02

Device Description : Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a

Device Class : 2

Duns Number: 118663297

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Fascile Continuous Peripheral Nerve Block Set - B372500003011 Catalog Number : 500003-01

Device Description : Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a

Device Class : 2

Duns Number: 118663297

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Fascile Continuous Peripheral Nerve Block Set - B372500003021 Catalog Number : 500003-02

Device Description : Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a

Device Class : 2

Duns Number: 118663297

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

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