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 - 00817740020119 Catalog Number : UTRT-5012A

Device Description : SECURE FIT BAR: HEAD AND NECK

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020126 Catalog Number : UTRT-5527A

Device Description : EXTENDED BUTTERFLY BOARD

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020133 Catalog Number : 00-0601

Device Description : MULT-TREATMENT BASE: GENERAL ASSEMBLY GEN-2

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020140 Catalog Number : 6026-00-02

Device Description : PB: PAD SET LOW PROFILE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020157 Catalog Number : EMRT-8305

Device Description : 2.4MM 10X12 EXTENDED U-FRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020164 Catalog Number : EMRT-8310

Device Description : 3.2MM 10X10 STANDARD U-FRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020171 Catalog Number : EMRT-8315

Device Description : 3.2MM 10X12 EXTENDED U-FRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020188 Catalog Number : EMRT-8320

Device Description : 2.4MM 10X10 ADVANTAGE U-FRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020195 Catalog Number : EMRT-8325

Device Description : 3.2MM 10X12 EXTENDED SECUREFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020201 Catalog Number : EMRT-8330

Device Description : 2.4MM HEAD ONLY SECUREFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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