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 - 00817740020317 Catalog Number : EMRT-8385

Device Description : 3.2MM HEAD & SHOULDER S-TYPE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020324 Catalog Number : EMRT-8400

Device Description : 2.4MM PERF: 18X24 PUNCHED ON 18" SIDE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020331 Catalog Number : EMRT-8405

Device Description : 2.4MM SOLID: 18X24 PUNCHED ON 18" SIDE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020348 Catalog Number : EMRT-8410

Device Description : 3.2MM PERF: 18X24 PUNCHED ON 18" SIDE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020355 Catalog Number : EMRT-8415

Device Description : 3.2MM SOLID: 18X24PUNCHED ON 18" SIDE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020362 Catalog Number : EMRT-8420

Device Description : 2.4MM PERF: 12X12

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020379 Catalog Number : EMRT-8425

Device Description : 3.2MM PERF: 12X12

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020386 Catalog Number : EMRT-8430

Device Description : EXTREMITY THERMOPLASTIC SHEETS

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020393 Catalog Number : EMRT-8440

Device Description : 3.2MM PERF: 18X24

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020409 Catalog Number : EMRT-8450

Device Description : 2.4MM PERF: 9X12 PUNCHED ON 9" SIDE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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