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) (6) Table, Operating-Room, Ac-Powered (FQO) (4)

Premarket Exempt

No Yes

Clear

2" 24" FLAT ARMBOARD PAD - 00842430100604 Catalog Number : 69442

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

ASSY, PAD, ARM BOARD, 3" - 00842430100611 Catalog Number : 5366-7000

Device Description : Pad for the model 5357 Mizuho OSI Pivoting Armboard. Made with Tempur-Pedic® Med Pad for the model 5357 Mizuho OSI Pivoting Armboard. 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 SET, 2” 3PC, SKYTRON 6000 - 00842430100628 Catalog Number :

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

PAD SET, 3” 3PC, SKYTRON 6000 - 00842430100635 Catalog Number :

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

FLAT ARMBOARD PAD, 1" X 24" - 00842430100642 Catalog Number : 69441

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, 4" 24" FLAT ARMBOARD - 00842430100659 Catalog Number : 69444

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, 2" 24" CONTOURED ARMBOARD - 00842430100666 Catalog Number : 69452

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, 3" 24" CONTOURED ARMBOARD - 00842430100673 Catalog Number : 69453

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 SET, 3” 3PC, SKYTRON 6700/6701 - 00842430100680 Catalog Number : 69473

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

PAD SET, 3” 3PC, SKYTRON 3501/3600 - 00842430100697 Catalog Number : 69483

Device Class : 1

Duns Number: 084527241

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

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