OSSUR AMERICAS, INC.

Address:27051 Towne Centre Drive,Foothill Ranch,CA,92610,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

TONG, SKULL FOR TRACTION (HAX) (10)

Premarket Exempt

No Yes

Clear

Halo Systems - 05690977308640 Catalog Number : 515300D

Device Description : OB RESOLVE RING KIT SM-No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977308657 Catalog Number : 515400D

Device Description : OB RESOLVE RING KIT STD-No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977308664 Catalog Number : 515500D

Device Description : OB RESOLVE RING KIT LG-No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977308671 Catalog Number : 515300V2

Device Description : OB V2 RING KIT TI SM-No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977308688 Catalog Number : 515400V2

Device Description : OB V2 RING KIT TI STD-No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977308695 Catalog Number : 515500V2

Device Description : OB V2 RING KIT TI LG-No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977308701 Catalog Number : JT-115

Device Description : J TONG MED/LGE-No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977308718 Catalog Number : JT-215

Device Description : J TONG SML/MED- No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977309333 Catalog Number : 505401C

Device Description : Kit Closed Back Halo Md

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977309340 Catalog Number : 505301C

Device Description : Kit Closed Back Halo Sm

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

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