BIONIX RADIATION THERAPY, LLC

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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

Accelerator, linear, medical (IYE) (10)

Premarket Exempt

Clear

BIONIX RADIATION THERAPY - 00817740020713 Catalog Number : SVRT-7650

Device Description : TRIVAC WITH BOLSTER CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020720 Catalog Number : SVRT-7715

Device Description : HEAD & SHOULDER 10L CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020737 Catalog Number : SVRT-7915

Device Description : 70X50CM 15L SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020744 Catalog Number : SVRT-9450

Device Description : 4D 100X100CM, 50L BLACK CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020751 Catalog Number : SVRT-9535

Device Description : 4D 100X70CM, 35L BLACK CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020768 Catalog Number : SVRT-9820

Device Description : 4D 70X70CM, 20L BLACK CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020775 Catalog Number : UTRT-5007

Device Description : PHILLIPS SECUREFIT BAR

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020782 Catalog Number : UTRT-5008

Device Description : GE SECUREFIT BAR

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020799 Catalog Number : UTRT-5009

Device Description : NUCLETRON BAR

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020805 Catalog Number : UTRT-5010A

Device Description : VARIAN SECURE FIT BAR

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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