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) (7) Endoscopic Injection Needle, Gastroenterology-Urology (FBK) (2) Endoscopic Irrigation/Suction System (OCX) (1)

Premarket Exempt

No Yes

Clear

ClearCap Distal Attachment - 08809327350636 Catalog Number :

Device Description : 15.7mm/13.3mm

Device Class :

Duns Number: 688256864

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

Clear-Jet Injection Catheter - 08809327350667 Catalog Number :

Device Description : 23G-4mm/ 0.1T/ 2,300mm/ Non-head

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Clear-Jet Injection Catheter - 08809327350674 Catalog Number :

Device Description : 23G-4mm/ 0.05T/ 2,300mm/ Non-head

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327350926 Catalog Number :

Device Description : 6mm/ Moderato/ Oval/ Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327350933 Catalog Number :

Device Description : 10mm/ Moderato/ Oval/ Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327350940 Catalog Number :

Device Description : 15mm/ Moderato/ Oval/ Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327350957 Catalog Number :

Device Description : 24mm/ Moderato/ Oval/ Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327350964 Catalog Number :

Device Description : 30mm/ Moderato/ Oval/ Rotation

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327350971 Catalog Number :

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

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

ClearGrasp Snare - 08809327350988 Catalog Number :

Device Description : 6mm/ Moderato/ 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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