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

Table, Operating-Room, Ac-Powered (FQO) (3) Cushion, Wheelchair (IMP) (2) Protector, Skin Pressure (FMP) (2) Table, Surgical With Orthopedic Accessories, Ac-Powered (JEA) (2) Support, Patient Position (CCX) (1)

Premarket Exempt

No Yes

Clear

Tempur-Pedic Wheel Chair Pad 18x18x3 in - 00842430100406 Catalog Number : 69463

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

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

TEMPUR-PEDIC WHEELCHAIR PAD 20"X18"X3" - 00842430100413 Catalog Number : 69464

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

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

PAD, CHEST, TEMPUR, SST - 00842430100420 Catalog Number : 5840-7569

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : JEA

Prescription Use : No

Device Count : 1

PAD, LEG, 1" - 00842430100437 Catalog Number : 6850-7590

Device Description : This pad is designed for use with the 6850-170 leg support.Dimensions: 10x7x1 in This pad is designed for use with the 6850-170 leg support.Dimensions: 10x7x1 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, TABLE, PERINEAL POST, 6875 HANA - 00842430100444 Catalog Number : 6875-7129

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

PAD, ARM, 1" - 00842430100451 Catalog Number : 6850-7600

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

HANA TABLE PAD - 00842430100468 Catalog Number : 6875-7120

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

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

PAD, TRANSFER, 3" - 00842430100475 Catalog Number : 5855-7377

Device Description : This pad is designed for use with various Mizuho OSI paient transfer boards.Dime This pad is designed for use with various Mizuho OSI paient transfer boards.Dimensions: 31x20x3 inches.Made with Tempur-Pedic® Medical materials

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : JEA

Prescription Use : No

Device Count : 1

Positioning Pad Set Tempur (6 pc) - 00842430100482 Catalog Number :

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

PAD SET, 3” 3PC, STERIS 3080/3085 - 00842430100499 Catalog Number : 69403

Device Class : 1

Duns Number: 084527241

Premarket Exempt : No

Product Code : FQO

Prescription Use : No

Device Count : 1

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