MIZUHO CORPORATION

Address:3-30-13 HONGO,BUNKYO-KU Tokyo,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

Table, Operating-Room, Electrical (GDC) (5) Retractor, Self-Retaining, For Neurosurgery (GZT) (3) Applier, Hemostatic Clip (HBT) (1) Instrument, Surgical, Non-Powered (HAO) (1)

Premarket Exempt

No Yes

Clear

GM-98 Spinal Frame - 04946329039924 Catalog Number : 02-120-00

Device Description : GM-98 Spinal Frame

Device Class : 1

Duns Number: 690677802

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : Yes

Device Count : 1

Four-point Spinal Frame - 04946329039931 Catalog Number : 02-121-00

Device Description : Four-point Spinal Frame

Device Class : 1

Duns Number: 690677802

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : Yes

Device Count : 1

Radiolucent Carbon Fiber Four Point Spinal Frame - 04946329039948 Catalog Number : 02-121-10

Device Description : Radiolucent Carbon Fiber Four Point Spinal Frame

Device Class : 1

Duns Number: 690677802

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : Yes

Device Count : 1

Arm-board - 04946329046731 Catalog Number : 03-001-73

Device Description : Aluminium Armboard

Device Class : 1

Duns Number: 690677802

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : Yes

Device Count : 1

Arm-board - 04946329046748 Catalog Number : 03-001-74

Device Description : Radiolucent Acrylic Armboard

Device Class : 1

Duns Number: 690677802

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : Yes

Device Count : 1

Dural Elevator - 04946329052701 Catalog Number : 07-008-23

Device Description : Dural Elevator, Flexible Shaft

Device Class : 1

Duns Number: 690677802

Premarket Exempt : Yes

Product Code : HAO

Prescription Use : Yes

Device Count : 1

Anastomosis Clip Applier - 04946329053739 Catalog Number : 07-097-00

Device Description : Anastomosis Clip Applier

Device Class : 1

Duns Number: 690677802

Premarket Exempt : No

Product Code : HBT

Prescription Use : Yes

Device Count : 1

SELF-RETAINING RETRACTOR - 04946329054606 Catalog Number : 07-157-01

Device Description : TAPERED SELF-RETAINING RETRACTOR 42cm

Device Class : 2

Duns Number: 690677802

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

SELF-RETAINING RETRACTOR - 04946329054613 Catalog Number : 07-157-02

Device Description : TAPERED SELF-RETAINING RETRACTOR 37cm

Device Class : 2

Duns Number: 690677802

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

SELF-RETAINING RETRACTOR - 04946329054620 Catalog Number : 07-158-01

Device Description : TAPERED SELF-RETAINING RETRACTOR 42cm W

Device Class : 2

Duns Number: 690677802

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

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