JET MEDICAL, 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

Port & Catheter, Implanted, Subcutaneous, Intravascular (LJT) (4) Introducer, Catheter (DYB) (2)

Premarket Exempt

No Yes

Clear

MICRO-STICK SET - 00810988021504 Catalog Number : JT100500002

Device Description : 5F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE, 4CM NEEDLE

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

MICRO-STICK SET - 00810988021511 Catalog Number : JT100500003

Device Description : 5F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE, 7CM NEEDLE

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

N/A - 00810988021603 Catalog Number :

Device Description : 6.6F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

N/A - 00810988021610 Catalog Number :

Device Description : 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

N/A - 00810988021627 Catalog Number :

Device Description : 6.6F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

N/A - 00810988021634 Catalog Number :

Device Description : 8F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

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