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) Prostate immobilizer rectal balloon (PCT) (1)

Premarket Exempt

Clear

BIONIX RADIATION THERAPY - 00817740021017 Catalog Number : ERB-90-FS

Device Description : ENDORECTAL BALLOON

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021031 Catalog Number : HNRT-3501

Device Description : Standard TruGuard

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021048 Catalog Number : EMRT-8331

Device Description : 3.2MM HEAD ONLY FREEVIEW VERSAFRAME SECUREFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021055 Catalog Number : SVRT-7108

Device Description : SecureVac Foot Switch

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021062 Catalog Number : HNRT-7011

Device Description : MoldCare Locator Device

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021178 Catalog Number : UTRT-7019

Device Description : CF MEDICAL INTELLIGENCE SECUREFIT BAR

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021208 Catalog Number : HNRT-7045

Device Description : VERSABOARD ACCESSORY ADAPTER

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021215 Catalog Number : SVRT-7131

Device Description : 80 CM X 150 CM 35L FILL SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021222 Catalog Number : SVRT-7132

Device Description : 80 CM X150 CM 47 L FILL SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021239 Catalog Number : SVRT-7133

Device Description : 80 CM X 150 CM 55L FILL SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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