TruGuard™

Basic Information

• Brand Name: TruGuard™
• Primary DI: 00714646000415
• Version / Model: HNRT-3501
• Catalog Number: HNRT-3501
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-01-08
• Public Version: 4
• Public Version Date: 2023-07-17
• Public Version Status: Update
• Public Device Record Key: 5ce3aa61-11f0-45e8-906a-a9fb2fbc60c4

Device Description

TruGuard, Standard

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, linear, medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61130	Radiological head/neck positioning mouthpiece	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10714646000412	GS1
Primary	00714646000415	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153270	000