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, Surgical With Orthopedic Accessories, Ac-Powered (JEA) (4) Support, Patient Position (CCX) (2)

Premarket Exempt

No Yes

Clear

HIP PAD, TEMPUR PEDIC COMFORT, MEDIUM - 00842430100307 Catalog Number : 6956-4

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : JEA

Prescription Use : No

Device Count : 1

HIP PAD, TEMPUR PEDIC COMFORT, SMALL - 00842430100314 Catalog Number : 6956-5

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : JEA

Prescription Use : No

Device Count : 1

THIGH PAD, TEMPUR PEDIC COMFORT, RIGHT - 00842430100321 Catalog Number : 6956-6

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

THIGH PAD, TEMPUR PEDIC COMFORT, LEFT - 00842430100338 Catalog Number : 6956-7

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

PILLOW, MODULAR TABLE STANDARD SLING - 00842430100345 Catalog Number : 6946

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

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

PILLOW, QUEEN, SLING, MODULAR TABLE - 00842430100352 Catalog Number : 6947

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

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

PAD, 5857 CROSS ARM SUPPORT - 00842430100369 Catalog Number : 5857-7000

Device Description : This pad is designed for use with the 5857 Cross Arm Support.Dimensions: 19x5x1 This pad is designed for use with the 5857 Cross Arm Support.Dimensions: 19x5x1 inches.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, ARMBOARD, 2" - 00842430100376 Catalog Number : 5356-7000

Device Description : This pad is designed for use with various Mizuho OSI Armboards.Dimensions: 24x6x This pad is designed for use with various Mizuho OSI Armboards.Dimensions: 24x6x2 inches.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, ARMBOARD, 1" - 00842430100383 Catalog Number : 5379-7722

Device Description : This pad is designed for use with various Mizuho OSI Armboards.Dimensions: 22x6x This pad is designed for use with various Mizuho OSI Armboards.Dimensions: 22x6x1 inches.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, SUPPORT, 1" - 00842430100390 Catalog Number : 5840-7030

Device Description : This pad is designed for use with various Mizuho OSI leg supports.Dimensions: 17 This pad is designed for use with various Mizuho OSI leg supports.Dimensions: 17x12x1 inches.Made with Tempur-Pedic® Medical materials

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

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