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) (9) Component, cast (LGF) (1)

Premarket Exempt

Clear

BIONIX RADIATION THERAPY - 00817740020010 Catalog Number : 5105-00-03

Device Description : PELVIS BELLY: GEN3 PAD SET ASSEMBLY W/ MEDIUM AND SMALL INSERTS

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020027 Catalog Number : BKRT-5037

Device Description : B-SECURE FOAM, MEDIUM, BULK CASE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020034 Catalog Number : BKRT-5036

Device Description : A-SECUREFOAM, SMALL, BULK CASE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020041 Catalog Number : BKRT-5036

Device Description : B-SECURE FOAM, SMALL, BULK CASE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020058 Catalog Number : BKRT-5038

Device Description : A-SECURE FOAM, LARGE, BULK CASE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020065 Catalog Number : BKRT-5038

Device Description : B-SECUREFOAM, LAGE, BULK CASE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020072 Catalog Number : EMRT-8300

Device Description : 2.4MM 10X10, STANDARD U-FRAME

Device Class : 1

Duns Number: 080397923

Premarket Exempt : No

Product Code : LGF

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020089 Catalog Number : PBRT-6025-03

Device Description : PRONE BREAST PAD SET: BASELESS

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020096 Catalog Number : SVRT-7535-A

Device Description : SECUREVAC 100X70, 35L FILL

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020102 Catalog Number : UTRT-7527

Device Description : CARBON FIBER EXTENDED BUTTERFLY BOARD

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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