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

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

Premarket Exempt

No Yes

Clear

MEDCOMP GEN III POWER INJECTABLE PORT - 00810988021191 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

MEDCOMP GEN III POWER INJECTABLE PORT - 00810988021207 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

MEDCOMP GEN III POWER INJECTABLE PORT - 00810988021214 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

MEDCOMP GEN III POWER INJECTABLE PORT - 00810988021221 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

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE - 00810988021269 Catalog Number :

Device Description : 0.018" (0.47MM) X 45CM NITINOL GUIDEWIRE

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE - 00810988021276 Catalog Number :

Device Description : 0.018" (0.47MM) X 45CM STAINLESS STEEL GUIDEWIRE

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

MICRO-STICK SET - 00810988021368 Catalog Number : JT070400002

Device Description : 4F REGULAR MICRO-STICK® INTRODUCER SET WITH STAINLESS STEEL GUIDEWIRE, 4CM NEEDLE

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

MICRO-STICK SET - 00810988021375 Catalog Number : JT070400003

Device Description : 4F REGULAR MICRO-STICK® INTRODUCER SET WITH STAINLESS STEEL GUIDEWIRE, 7CM NEEDLE

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

MICRO-STICK SET - 00810988021382 Catalog Number : JT070500002

Device Description : 5F REGULAR MICRO-STICK® INTRODUCER SET WITH STAINLESS STEEL GUIDEWIRE, 4CM NEEDLE

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

MICRO-STICK SET - 00810988021399 Catalog Number : JT070500003

Device Description : 5F REGULAR MICRO-STICK® INTRODUCER SET WITH STAINLESS STEEL GUIDEWIRE, 7CM NEEDLE

Device Class : 2

Duns Number: 079506014

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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