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 - 00817740020416 Catalog Number : EMRT-8455

Device Description : 3.2MM PERF: 9X12 PUNCHED ON 9"SIDE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020423 Catalog Number : EMRT-8740

Device Description : 2.4MM HEAD ONLY FRAME & 8332-10 POSTERIOR FRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020430 Catalog Number : HNRT-5029

Device Description : PRONE ATTACHMENT

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020447 Catalog Number : HNRT-5039

Device Description : SUPRONE PLUS HEAD & NECK BOARD

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020454 Catalog Number : HNRT-5049

Device Description : LATERAL ATTACHMENT

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020461 Catalog Number : HNRT-6039

Device Description : T-FORM SUPRONE PLUS BOARD

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020478 Catalog Number : HNRT-6042

Device Description : PREMIUM SHOULDER SUPPRESSION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020485 Catalog Number : HNRT-6060

Device Description : EXTREMITY IMMOBILIZER

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020492 Catalog Number : HNRT-7029

Device Description : CARBON FIBER PRONE ATTACHMENT SUPRONE PLUS

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020508 Catalog Number : HNRT-7040

Device Description : VERSABOARD

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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