HeadFIX P10103-410

GUDID 04056719001971

A single HeadFIX Marking Set comprises 3 marking plates for the HeadFIX Localizers. These plates assist in patient positioning and light field verific

Medical Intelligence Medizintechnik GmbH

Stereotactic radiosurgical/radiotherapy arch head frame

• Primary Device ID: 04056719001971
• NIH Device Record Key: a9363f4d-6e4c-4c14-9590-e00795355d8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeadFIX
• Version Model Number: P10103-410
• Catalog Number: P10103-410
• Company DUNS: 314546664
• Company Name: Medical Intelligence Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056719001971 [Primary]

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-23

On-Brand Devices [HeadFIX]

• 04056719002008: HeadFIX® Angulating Fixation Set long is for the attachment of the mouthpiece module allowing t
• 04056719001995: HeadFIX® Angulating Fixation Set is for the attachment of the mouthpiece module allowing the pa
• 04056719001971: A single HeadFIX Marking Set comprises 3 marking plates for the HeadFIX Localizers. These plates
• 04056719001964: HeadFIX® Nosepiece Hygienic Cover is a foil which is used when the nasal impression is made on
• 04056719001957: HeadFIX® Friction Plates (Set of 20) are used with the HeadFIX Angulating Fixation Set and must
• 04056719000448: The HeadFIX® Mouthpiece Large is affixed to the HeadFIX Angulating Fixation Set assuring safe
• 04056719000431: The HeadFIX® Mouthpiece Medium is affixed to the HeadFIX Angulating Fixation Set assuring safe
• 04056719001841: The HeadFIX® Mouthpiece Small is affixed to the HeadFIX Angulating Fixation Set assuring safe
• 04056719000400: The HeadFIX® Nosepiece set contains five nosepieces for assuring safe immobilization and preci
• 04056719000394: The HeadFIX® Mouthpiece X-large P2 is affixed to the HeadFIX Angulating Fixation Set assuring
• 04056719000387: The HeadFIX® Mouthpiece Small P2 is affixed to the HeadFIX Angulating Fixation Set assuring sa
• 04056719000370: HeadFIX® Saliva Stop is connected between the vacuum pump and the mouthpiece preventing saliva
• 04056719000417: A single HeadFIX® Marking Set HEAD&NECK comprises 3 marking plates for the HeadFIX Localizers.
• 04056719000363: HeadFIX® Patient Set CRANIAL P2 include a standard angulating fixation set, a BlueBAG and the
• 04056719000356: A single HeadFIX® Marking Set CRANIAL P2 comprises 3 marking plates for the HeadFIX Localizers
• 04056719000349: HeadFIX® Vacuum Pump Set is a tubing set including all necessary tubes for the vacuum pump.