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

Catheter And Tip, Suction (JOL) (2) Apparatus, Electrosurgical (HAM) (1) Transilluminator, Ac-Powered (HJM) (1)

Premarket Exempt

Yes

Clear

ESI - B396MSK1009120 Catalog Number :

Device Description : LIGHT ATTACHMENT FOR MEGADYNE CAUTERY PEN. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HAM

Prescription Use : No

Device Count : 1

ESI - B396MSK1116050 Catalog Number :

Device Description : MIRA TRANSILLUMINATOR/ PILLING EYE LIGHT. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HJM

Prescription Use : No

Device Count : 1

ESI - B396MSK1122110 Catalog Number :

Device Description : CUSTOM FRAZIER SUCTION, 30 DEGREE. INSTRUMENT HAS 5.5" WORKING LENGTH. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : No

Device Count : 1

ESI - B396SK2219820 Catalog Number :

Device Description : CUSTOM MFG'D YANKAUER SUCTION TUBE, ACMI FITTING. PER DRAWING SK-22198-2.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : No

Device Count : 1

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