Mouthpiece (small)


Product Overview

Mouthpiece (small)
Precise Bite™ - MTCBPBITES


Device Description

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.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: IYE

Device Name: Accelerator, Linear, Medical

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.5050

Third Party Flag: N

Medical Specialty: RA


Code: LNH

Device Name: System, Nuclear Magnetic Resonance Imaging

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1000

Third Party Flag: Y

Medical Specialty: RA


Device Identifiers

Device Id: 00841439104071

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


Device Id: 10841439104078

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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