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

Endoscopic Irrigation/Suction System (OCX) (6) Forceps, Biopsy, Non-Electric (FCL) (3) Biopsy Needle (FCG) (1)

Premarket Exempt

No Yes

Clear

Clear-Bite Biopsy Forceps - 08809327352623 Catalog Number :

Device Description : Φ2.3/ 2,400mm/ Oval

Device Class : 1

Duns Number: 688256864

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 1

Clear-Bite Biopsy Forceps - 08809327352647 Catalog Number :

Device Description : Φ2.3/ 2,300mm/ Needle

Device Class :

Duns Number: 688256864

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 1

Clear-Bite Biopsy Forceps - 08809327352654 Catalog Number :

Device Description : Φ2.3/ 2,300mm/ Round/ Coated

Device Class : 1

Duns Number: 688256864

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 1

ClearCap Distal Attachment - 08809327352807 Catalog Number :

Device Description : 15mm/12.6mm

Device Class :

Duns Number: 688256864

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ClearCap Distal Attachment - 08809327352814 Catalog Number :

Device Description : 11.8mm/9.4mm

Device Class :

Duns Number: 688256864

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ClearCap Distal Attachment - 08809327352821 Catalog Number :

Device Description : 11.35mm/8.9mm

Device Class :

Duns Number: 688256864

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ClearCap Distal Attachment - 08809327352838 Catalog Number :

Device Description : 12.4mm/10mm

Device Class :

Duns Number: 688256864

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ClearCap Distal Attachment - 08809327352845 Catalog Number :

Device Description : 13.4mm/11mm

Device Class :

Duns Number: 688256864

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ClearCap Distal Attachment - 08809327352852 Catalog Number :

Device Description : 14mm/11.6mm

Device Class :

Duns Number: 688256864

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

ClearTip - 08809327352920 Catalog Number :

Device Description : EUS-FNA 19G

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

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