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) (10)

Premarket Exempt

Yes

Clear

ESI - B3961540120 Catalog Number :

Device Description : SALVATI OPERATING PROCTOSCOPE, 4CM X 19CM, INSULATED. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B396154012LC0 Catalog Number :

Device Description : REPLACEMENT LIGHT CARRIER ONLY FOR 4CM X 19CM INSULATED SALVATI PROCTOSCOPE. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B3961540130 Catalog Number :

Device Description : SALVATI OPERATING PROCTOSCOPE, 4CM X 12CM, INSULATED. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B396154013LC0 Catalog Number :

Device Description : REPLACEMENT LIGHT CARRIER ONLY FOR 4CM X 12CM INSULATED SALVATI PROCTOSCOPE. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B396154013O0 Catalog Number :

Device Description : OBTURATOR ONLY FOR 4CM X 12CM SALVATI OPERATING PROCTOSCOPE

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B396154013S0 Catalog Number :

Device Description : SALVATI OPERATING PROCTOSCOPE SHEATH ONLY. 4CM X 12CM WITH INSULATING COATING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B3961540140 Catalog Number :

Device Description : MODIFIED OPERATING PROCTOSCOPE, 3.25CM X 20CM, STAINLESS. ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B396154014O0 Catalog Number :

Device Description : OBTURATOR AND FIBER OPTIC LIGHT CARRIER ONLY FOR CUSTOM MODIFIED OPERATING PROCTOSCOPE.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B3961550100 Catalog Number :

Device Description : ULTRASONIC RECTAL PROBE INTRODUCING PROCTOSCOPE, 20CM, ACMI FITTING.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

ESI - B396155010O0 Catalog Number :

Device Description : OBTURATOR ONLY FOR ULTRASONIC RECTAL PROBE INTRODUCING PROCTOSCOPE, 20 CM.

Device Class : 2

Duns Number: 002212793

Premarket Exempt : Yes

Product Code : GCF

Prescription Use : No

Device Count : 1

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