BIONIX RADIATION THERAPY, LLC

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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

Accelerator, linear, medical (IYE) (10)

Premarket Exempt

Clear

BIONIX RADIATION THERAPY - 00817740020614 Catalog Number : SVRT-7107

Device Description : SECUREVAC ADAPTOR FOR HOSPITAL VAC

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020621 Catalog Number : SVRT-7130

Device Description : 150CM X 70 CM, 55L SECUREVAC

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020638 Catalog Number : SVRT-7135

Device Description : 32X5X9CM, 2L VERSACUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020645 Catalog Number : SVRT-7136

Device Description : 2.5L FILL EXT SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020652 Catalog Number : SVRT-7140

Device Description : 100X70CM, 35L PELIVC PORTAL SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020669 Catalog Number : SVRT-7380-A

Device Description : 100X150CM, 80L SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020676 Catalog Number : SVRT-7450-A

Device Description : 100X100CM, 50L SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020683 Catalog Number : SVRT-7600

Device Description : TRIVAC WITHOUT BOLSTER CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020690 Catalog Number : SVRT-7625

Device Description : T-VAC SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020706 Catalog Number : SVRT-7820-A

Device Description : 70X70CM, 20L SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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