FDA.reportPublic FDA data

BIONIX RADIATION THERAPY

Primary DI
10817740021038
Brand
BIONIX RADIATION THERAPY
Company
BIONIX RADIATION THERAPY, LLC
Model
HNRT-3501
Catalog number
HNRT-3501
Device description
Standard TruGuard
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153270000TruGuard Custom Tongue and Jaw PositionerBionix Development Corp.2016-03-08IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817740021038PackageGS15In Commercial Distribution
00817740021031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081774002103810817740021038
00817740021031008177400210318177400210310817740021031

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning thermoplastic mould materialA thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080397923
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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