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

Support, Patient Position (CCX) (5) Table, Operating-Room, Ac-Powered (FQO) (5)

Premarket Exempt

No Yes

Clear

PAD, 2" FT, W/ PL, 6940,STERIS 3080/3085 - 00842430100901 Catalog Number : 69402F

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, 2", HD, 6940, 3080/3085 - 00842430100918 Catalog Number : 69402H

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, BK 6940 3", W/PL STERIS 3080/3085 - 00842430100925 Catalog Number : 69403B

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, FT 6940 3", W/PL STERIS 3080/3085 - 00842430100932 Catalog Number : 69403F

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, HD 6940 3", STERIS 3080/3085 - 00842430100949 Catalog Number : 69403H

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

BLOCK, KNEE, A, TEMPUR-MED - 00842430100956 Catalog Number : 6950-01

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

BLOCK, KNEE, B, TEMPUR-MED - 00842430100963 Catalog Number : 6950-02

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

ROLL, BASIC, TEMPUR-MED - 00842430100970 Catalog Number : 6950-03

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

WEDGE, SPINAL, TEMPUR-MED - 00842430100987 Catalog Number : 6950-04

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

BLOCK, CRADLE, TEMPUR-MED - 00842430100994 Catalog Number : 6950-05

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

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