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) (8) Pack, hot or cold, water circulating (ILO) (2)

Premarket Exempt

No Yes

Clear

Halo Systems - 05690977305892 Catalog Number : 505400T

Device Description : CB RING KIT TI STD

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977305908 Catalog Number : 505500T

Device Description : CB RING KIT TI LG

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977305915 Catalog Number : 505300V2

Device Description : OPEN BACK GLASS HALO SM

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977305922 Catalog Number : 505400V2

Device Description : OPEN BACK GLASS HALO STD

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Cold Rush - 05690977306097 Catalog Number : B-232000011

Device Description : Kit Cold Rush US w/ Knee Pad

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Cold Rush - 05690977306233 Catalog Number : B-232000012

Device Description : Kit Cold Rush US w/ Unv Pad

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977307599 Catalog Number : 531C

Device Description : PRESET TORQUE SCREWDRIVER 8LB

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977308596 Catalog Number : 515300C

Device Description : CB 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 - 05690977308626 Catalog Number : 515400C

Device Description : CB 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 - 05690977308633 Catalog Number : 515500C

Device Description : CB RESOLVE RING KIT LG-No App

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

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