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) (7) Pack, hot or cold, water circulating (ILO) (3)

Premarket Exempt

No Yes

Clear

Halo Systems - 05690977197282 Catalog Number : JT-200

Device Description : J TONG ASSEMBLY SML/MED

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977197299 Catalog Number : JT-110

Device Description : J TONG ONLY MED/LGE

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977197305 Catalog Number : JT-210

Device Description : J TONG ONLY SML/MED

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977197312 Catalog Number : 505300D

Device Description : OB RESOLVE STERILE UNIT SML

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977197329 Catalog Number : 505400D

Device Description : OB RESOLVE STERILE UNIT STD

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977197336 Catalog Number : 505500D

Device Description : OB RESOLVE STERILE UNIT LGE

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977197404 Catalog Number : 540D

Device Description : OB RESOLVE COMPONENT TRAY

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Cold Rush - 05690977198517 Catalog Number : B-232000010

Device Description : Cold Rush Device USA

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Cold Rush - 05690977198524 Catalog Number : B-232002000

Device Description : Cold Rush Knee Pad

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Cold Rush - 05690977198531 Catalog Number : B-232602100

Device Description : Cold Rush Hip Pad LT

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

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