HAKKO CO.,LTD.

HAKKO CO.,LTD.

Address:1490 O-aza Isobe,CHIKUMA-SHI Nagano,JP

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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

Instrument, Biopsy (KNW) (4) Needle, Conduction, Anesthetic (W/Wo Introducer) (BSP) (4) Biopsy Needle Kit (FCG) (2)

Premarket Exempt

No

Clear

BIOSUC-C7 - 04526737120003 Catalog Number :

Device Description : 20G x 50mmwith suction syringe

Device Class :

Duns Number: 693273427

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

BIOSUC-C7 - 04526737120010 Catalog Number :

Device Description : 20G x 100mmwith suction syringe

Device Class : 2

Duns Number: 693273427

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

BIOSUC-C7 - 04526737120027 Catalog Number :

Device Description : 22G x 50mmwith suction syringe

Device Class :

Duns Number: 693273427

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

BIOSUC-C7 - 04526737120034 Catalog Number :

Device Description : 22G x 100mmwith suction syringe

Device Class :

Duns Number: 693273427

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Sonopsy-C1 - 04526737120041 Catalog Number :

Device Description : 1 21G x 50mm biopsy needle with suction syringe3 Filter paper

Device Class : 2

Duns Number: 693273427

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

Sonopsy-C1 - 04526737120058 Catalog Number :

Device Description : 1 21G x 100mm biopsy needle with suction syringe3 Filter paper

Device Class : 2

Duns Number: 693273427

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

PTC Spinal Needle - 04526737120065 Catalog Number :

Device Description : 18G x 6"(152mm)Plastic hub, depth guideRough surface, calibrations

Device Class : 2

Duns Number: 693273427

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

PTC Spinal Needle - 04526737120072 Catalog Number :

Device Description : 18G x 8"(203mm)Plastic hub, depth guideRough surface, calibrations

Device Class :

Duns Number: 693273427

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

PTC Spinal Needle - 04526737120089 Catalog Number :

Device Description : 20G x 6"(152mm)Plastic hub, depth guideRough surface, calibrations

Device Class : 2

Duns Number: 693273427

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

PTC Spinal Needle - 04526737120096 Catalog Number :

Device Description : 20G x 8"(203mm)Plastic hub, depth guideRough surface, calibrations

Device Class :

Duns Number: 693273427

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

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