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 Injection Needle, Gastroenterology-Urology (FBK) (6) Forceps, Biopsy, Non-Electric (FCL) (4)

Premarket Exempt

No Yes

Clear

Clear-Jet Injection Catheter - 08809327352388 Catalog Number :

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

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Clear-Jet Injection Catheter - 08809327352395 Catalog Number :

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

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Clear-Jet Injection Catheter - 08809327352401 Catalog Number :

Device Description : 23G-4mm/ 0.05T/ 1,800mm

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Clear-Jet Injection Catheter - 08809327352418 Catalog Number :

Device Description : 23G-4mm/ 0.1T/ 1,800mm

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Clear-Jet Injection Catheter - 08809327352425 Catalog Number :

Device Description : 23G-4mm/ 0.08T/ 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 - 08809327352432 Catalog Number :

Device Description : 23G-6mm/ 0.1T/ 2,300mm

Device Class : 2

Duns Number: 688256864

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

Clear-Bite Biopsy Forceps - 08809327352548 Catalog Number :

Device Description : Φ1.72/ 1,600mm/ Oval

Device Class : 1

Duns Number: 688256864

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 1

Clear-Bite Biopsy Forceps - 08809327352562 Catalog Number :

Device Description : Φ1.72/ 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 - 08809327352586 Catalog Number :

Device Description : Φ2.3/ 1,600mm/ Oval

Device Class : 1

Duns Number: 688256864

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 1

Clear-Bite Biopsy Forceps - 08809327352616 Catalog Number :

Device Description : Φ2.3/ 1,600mm/ Round/ Coated

Device Class : 1

Duns Number: 688256864

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 1

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