MIZUHO ORTHOPEDIC SYSTEMS, INC.

Address:30031 AHERN AVE,UNION CITY,CA,94587,US

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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

Protector, Skin Pressure (FMP) (4) Table, Operating-Room, Ac-Powered (FQO) (3) Table, Surgical With Orthopedic Accessories, Ac-Powered (JEA) (2) Table, Operating-Room, Electrical (GDC) (1)

Premarket Exempt

No Yes

Clear

PAD SET, 3” 3PC, SKYTRON 3500AMSCO C-MAX - 00842430100703 Catalog Number : 69493

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

PAD SET, 3.5” 3PC, STERIS 3080/3085 - 00842430100710 Catalog Number : 694035

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

PAD, ARMBOARD, FLAT, 1" x 26" - 00842430100727 Catalog Number : 694461

Device Description : Made with Tempur-Pedic® Medical materials.

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PAD, CONTOURED ARMBOARD, 3" X 26" - 00842430100734 Catalog Number : 694563

Device Description : Made with Tempur-Pedic® Medical materials.

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PAD, CONTOURED ARMBOARD, 4" X 26" - 00842430100741 Catalog Number : 694564

Device Description : Made with Tempur-Pedic® Medical materials.

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PAD, CENTER, MONTREAL, 18X12X1 - 00842430100758 Catalog Number : 5875-7009

Device Description : Part of the model 5875 Mizuho OSI Montreal Lateral Positioner. Made with Tempur- Part of the model 5875 Mizuho OSI Montreal Lateral Positioner. Made with Tempur-Pedic® Medical materials.

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

ARM BOARD PAD W/ TEMPUR 610 x 152 x 76mm - 00842430100765 Catalog Number : 8000-7050-1

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : No

Device Count : 1

RAISED CHEST SUPPORT PLATE - 00842430100772 Catalog Number : 7887-831

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : JEA

Prescription Use : No

Device Count : 1

ASSY, PAD, CHEST, FLAT, NON-ACP - 00842430100789 Catalog Number : 6844-170

Device Description : Made with Tempur-Pedic® Medical materials.

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : JEA

Prescription Use : No

Device Count : 1

PAD, SUPINE TOP - 00842430100796 Catalog Number : 6844-175

Device Description : Fits the Mizuho OSI Insite® Surgery Table Supine Top. Made with Tempur-Pedic® Me Fits the Mizuho OSI Insite® Surgery Table Supine Top. Made with Tempur-Pedic® Medical materials.

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

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