FINEMEDIX CO.,LTD.

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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

Snare, Flexible (FDI) (9) Endoscopic Injection Needle, Gastroenterology-Urology (FBK) (1)

Premarket Exempt

No Yes

Clear

ClearGrasp Snare - 08809327350995 Catalog Number :

Device Description : 10mm/ Moderato/ Oval/ Non-Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327351008 Catalog Number :

Device Description : 15mm/ Moderato/ Oval/ Non-Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327351015 Catalog Number :

Device Description : 24mm/ Moderato/ Oval/ Non-Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327351022 Catalog Number :

Device Description : 30mm/ Moderato/ Oval/ Non-Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327351039 Catalog Number :

Device Description : 6mm/ Stiff/ Oval/ Non-Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

Clear-Jet Injection Catheter - 08809327351084 Catalog Number :

Device Description : 23G-6mm/ 0.05T/ 2,300mm

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327351664 Catalog Number :

Device Description : 6mm/ Soft/ Oval/ Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327351671 Catalog Number :

Device Description : 6mm/ Stiff/ Oval/ Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327351688 Catalog Number :

Device Description : 10mm/ Soft/ Oval/ Non-Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327351695 Catalog Number :

Device Description : 10mm/ Stiff/ Oval/ Non-Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

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