FTT 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

Apparatus, Electrosurgical (HAM) (9) Catheter And Tip, Suction (JOL) (1)

Premarket Exempt

Yes

Clear

ESI - B3964102760 Catalog Number :

Device Description : Rectal Suction Tube for Cleveland Clinic

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : No

Device Count : 1

ESI - B3964500140 Catalog Number :

Device Description : SNARE EXTENSION TUBE ONLY.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B3964500160 Catalog Number :

Device Description : DISPOSABLE SNARE WIRES, SPRING WIRE, ONE DOZEN.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B3964500180 Catalog Number :

Device Description : DISPOSABLE SNARE WIRES, SOFT WIRE, ONE DOZEN.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B3964500200 Catalog Number :

Device Description : DISPOSABLE SNARE WIRES, STRANDED WIRE, ONE DOZEN.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B3964500300 Catalog Number :

Device Description : BALL ELECTRODE FOR CAUTERY SNARE, 6MM BALL.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B3964500320 Catalog Number :

Device Description : BALL ELECTRODE, USE WITH SNARE, 3MM.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B3964500500 Catalog Number :

Device Description : ESI SUCTION CAUTERY, 6MM BALL, 37CM.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B3964500540 Catalog Number :

Device Description : ESI SUCTION CAUTERY, 3MM BALL, 37 CM.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B3964500600 Catalog Number :

Device Description : LIGHT & SUCTION ATTACHMENT FOR CAUTERY PENCIL. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

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