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

Proctoscope (GCF) (4) Transilluminator, Ac-Powered (HJM) (4) Anoscope And Accessories (FER) (1) Speculum, Vaginal, Nonmetal (HIB) (1)

Premarket Exempt

Yes

Clear

ESI - B396050080VT0 Catalog Number :

Device Description : FIBER OPTIC CABLE AND HANDSET FOR VENUS TRANSILLUMINATOR.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HJM

Prescription Use : No

Device Count : 1

ESI - B396050100VT0 Catalog Number :

Device Description : ESI VENOUS TRANSILLUMINATOR INCLUDING LIGHT SOURCE, HAND REST AND FLOOR STAND.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HJM

Prescription Use : No

Device Count : 1

ESI - B3960501020 Catalog Number :

Device Description : ESI STRAIGHT TRANSILLUMINATOR, 1/4" DIAMETER, ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HJM

Prescription Use : No

Device Count : 1

ESI - B3960501120 Catalog Number :

Device Description : 1/8" DIAMETER TRANSILLUMINATOR, ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HJM

Prescription Use : No

Device Count : 1

ESI GloSpec - B3961403100 Catalog Number : 14-0310

Device Description : Single use vaginal speculum with built in light source size small

Device Class :

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 1

ESI - B39615001700 Catalog Number :

Device Description : CCF HIRSCHMAN ANOSCOPE, 5/8" DIAMETER x 2-1/2" LONG WITH ROUNDED OBTURATOR TIP. CCF HIRSCHMAN ANOSCOPE, 5/8" DIAMETER x 2-1/2" LONG WITH ROUNDED OBTURATOR TIP. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : FER

Prescription Use : No

Device Count : 1

ESI - B3961501500 Catalog Number :

Device Description : YEOMAN SIGMOIDOSCOPE, 1/2" DIAMETER, SPECIFY WORKING LENGTH WITH DILATING WIND YEOMAN SIGMOIDOSCOPE, 1/2" DIAMETER, SPECIFY WORKING LENGTH WITH DILATING WINDOW AND FIBEROPTIC LIGHT ASSEMBLY. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B3961501520 Catalog Number :

Device Description : YEOMAN SIGMOIDOSCOPE, 3/4" DIAMETER, SPECIFY WORKING LENGTH WITH DILATING WIN YEOMAN SIGMOIDOSCOPE, 3/4" DIAMETER, SPECIFY WORKING LENGTH WITH DILATING WINDOW AND FIBEROPTIC LIGHT ASSEMBLY. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B3961501540 Catalog Number :

Device Description : YEOMAN SIGMOIDOSCOPE, 7/8" DIAMETER, SPECIFY WORKING LENGTH WITH DILATING WIND YEOMAN SIGMOIDOSCOPE, 7/8" DIAMETER, SPECIFY WORKING LENGTH WITH DILATING WINDOW AND FIBEROPTIC LIGHT ASSEMBLY. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B3961501580 Catalog Number :

Device Description : REPLACEMENT DILATING WINDOW FOR YEOMAN SIGMOIDOSCOPE OR ULTRASOUND PROCTOSCOPE

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

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