FDA.reportPublic FDA data

BIONIX RADIATION THERAPY

Primary DI
00817740020942
Brand
BIONIX RADIATION THERAPY
Company
Bionix Radiation Therapy, LLC
Model
HNRT-3500
Catalog number
HNRT-3500
Device description
LARGE TRUGUARD
Published
2017-04-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817740020949PackageGS15Not in Commercial Distribution
00817740020942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081774002094910817740020949
00817740020942008177400209428177400209420817740020942

GMDN Terms#

Term, Definition table
TermDefinition
Radiological head/neck positioning mouthpieceA non-sterile device intended to be used to position and immobilize a patient’s head for reproducible positioning during serial imaging studies, radiation treatment planning, or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS), on all parts of the brain, head, and neck. It is in the form of a custom-made bite assembly that can be used with an arch head frame or a thermoplastic mask. This is a reusable device intended for single-patient use.

Contacts#

Phone, Email table
PhoneEmail
+1(800)624-6649xxx@xxx.xxx

Regulatory Flags#

DUNS number
080397923
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817740020027BIONIX RADIATION THERAPYBKRT-5037BKRT-50372017-04-25
00817740020034BIONIX RADIATION THERAPYBKRT-5036BKRT-50362017-04-25
00817740020041BIONIX RADIATION THERAPYBKRT-5036BKRT-50362017-04-25
00817740020058BIONIX RADIATION THERAPYBKRT-5038BKRT-50382017-04-25
00817740020065BIONIX RADIATION THERAPYBKRT-5038BKRT-50382017-04-25
00817740020072BIONIX RADIATION THERAPYEMRT-8300EMRT-83002017-04-25
00817740020157BIONIX RADIATION THERAPYEMRT-8305EMRT-83052017-04-25
00817740020164BIONIX RADIATION THERAPYEMRT-8310EMRT-83102017-04-25
00817740020171BIONIX RADIATION THERAPYEMRT-8315EMRT-83152017-04-25
00817740020188BIONIX RADIATION THERAPYEMRT-8320EMRT-83202017-04-25
00817740020195BIONIX RADIATION THERAPYEMRT-8325EMRT-83252017-04-25
00817740020201BIONIX RADIATION THERAPYEMRT-8330EMRT-83302017-04-25
00817740020218BIONIX RADIATION THERAPYEMRT-8335EMRT-83352017-04-25
00817740020225BIONIX RADIATION THERAPYEMRT-8340EMRT-83402017-04-25
00817740020232BIONIX RADIATION THERAPYEMRT-8345EMRT-83452017-04-25
00817740020249BIONIX RADIATION THERAPYEMRT-8350EMRT-83502017-04-25
00817740020256BIONIX RADIATION THERAPYEMRT-8355EMRT-83552017-04-25
00817740020263BIONIX RADIATION THERAPYEMRT-8360EMRT-83602017-04-25
00817740020270BIONIX RADIATION THERAPYEMRT-8365EMRT-83652017-04-25
00817740020287BIONIX RADIATION THERAPYEMRT-8370EMRT-83702017-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21
00850065937168eMotusEMPNIA INC.IYE2026-09-21
00850065937175eMotusEMPNIA INC.IYE2026-09-21
00850065937182eMotusEMPNIA INC.IYE2026-09-21
00850065937199eMotusEMPNIA INC.IYE2026-09-21
00850065937205eMotusEMPNIA INC.IYE2026-09-21
00850065937212eMotusEMPNIA INC.IYE2026-09-21