NEO MEDICAL INC.

Address:1375 Greg St Ste 108,Sparks,NV,89431,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

Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days (LJS) (3) Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days (FOZ) (3) Introducer, Syringe Needle (KZH) (2) Stimulator, Nerve (ETN) (2)

Premarket Exempt

No Yes

Clear

NeoMagic - B339404316080 Catalog Number : 4043-1608

Device Description : 4.0Fr (18ga) x 8cm Single Lumen EPIV with Stylet

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

V-Cath - B33940530030 Catalog Number : 4053-003

Device Description : 4.0Fr x 10cm Tearaway Sheath Dilator Introducer Set

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : KZH

Prescription Use : Yes

Device Count : 1

V-Cath - B3394071660 Catalog Number : 407-166

Device Description : 4.0Fr x 60cm Single Lumen PICC with Insertion Components

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

NeoMagic - B339407616080 Catalog Number : 4076-1608

Device Description : 4.0Fr (18ga) x 8cm Single Lumen EPIV with Stylet and Introducer

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

V-Cath - B3394081620 Catalog Number : 408-162

Device Description : 4.0Fr x 20cm Single Lumen Midline with Safety OTN

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

Power V-Cath - B339409116600 Catalog Number : 4091-1660

Device Description : 4.0Fr x 60cm Single Lumen Power Rated PICC 5cm Tearaway, Nitinol 0.018 x 40cm wi 4.0Fr x 60cm Single Lumen Power Rated PICC 5cm Tearaway, Nitinol 0.018 x 40cm wire, 7cm Safety GWI

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

Power V-Cath - B339409216600 Catalog Number : 4092-1660

Device Description : 4.0Fr x 60cm Single Lumen Power Rated PICC, 10cm Tearaway, Nitinol Tungsten 0.01 4.0Fr x 60cm Single Lumen Power Rated PICC, 10cm Tearaway, Nitinol Tungsten 0.018 x 80cm marked wire, 7cm Safety GWI

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

V-Cath - B3395000080 Catalog Number : 500-008

Device Description : 5.0Fr x 10cm IR Seldinger Introducer Kit

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : KZH

Prescription Use : Yes

Device Count : 1

NeuroTrace - B339500020 Catalog Number : 500-02

Device Description : Neuro-Trace II Nerve Locator

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : ETN

Prescription Use : Yes

Device Count : 1

NeuroTrace - B339501120 Catalog Number : 501-12

Device Description : Neuro-Trace II Lead Cable

Device Class : 2

Duns Number: 015510540

Premarket Exempt : No

Product Code : ETN

Prescription Use : Yes

Device Count : 1

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