Fraxion P10106-321

GUDID 04056719001766

The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed

Medical Intelligence Medizintechnik GmbH

Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame

• Primary Device ID: 04056719001766
• NIH Device Record Key: 9642a873-36ee-4c2f-bce9-9a5980622574
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fraxion
• Version Model Number: P10106-321
• Catalog Number: P10106-321
• Company DUNS: 314546664
• Company Name: Medical Intelligence Medizintechnik GmbH
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	04056719001599 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	04056719001766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112210

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

On-Brand Devices [Fraxion]

• 04056719001797: The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization a
• 04056719001612: The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization a
• 04056719001605: The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization a
• 04056719001766: The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization a
• 04056719001759: The FRAXION™ Mouthpiece is affixed to the Fraxion Frontpiece assuring safe immobilization and
• 04056719001650: The Fraxion FRAXION™ Preparation Kit includes individual patient storage boxes and all necessa
• 04056719001643: "The Fraxion FRAXION™ Kit includes all necessary components to generate a patient-specific mou
• 04056719001636: The FRAXION™ Headrest EC allows to treat patients from Leksell Gamma Knife® Perfexion™ to L
• 04056719001575: Fraxion™ Vacuum Pump provides vacuum to fix the Fraxion™ Mouthpiece and to evacuate the Frax
• 04056719001568: The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patien
• 04056719001551: The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patien
• 04056719001544: The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patien
• 04056719001537: The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patien
• 04056719001520: The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patien
• 04056719001513: The FRAXION™ Marking Sheets are used togethter with the FRAXION™ Stereotactic Frame in order
• 04056719001506: FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatm
• 04056719001490: FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatm
• 04056719001483: FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatm
• 04056719001476: FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatm
• 04056719001469: FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatm
• 04056719001452: FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatm
• 04056719001445: The protective covers are attached to the U-Frame and protect patients head during setup.
• 04056719001438: The FRAXION™ Headrest ST is attached to the U-Frame to support the patient head.
• 04056719001421: Fraxion™ Spacer
• 04056719001414: The FRAXION™ Head Support Module ST is the main component of the system. It provides the inter
• 04056719001407: The FRAXION™ Head Support Module FX is the main component of the system. It provides the inter
• 04056719001391: The indexed FRAXION™ CT Adapter allows you to prepare patients for CT imaging.
• 04056719001384: "The FRAXION™ Stereotactic Frame is for target localization in stereotactic radiation therapy
• 04056719001377: The FRAXION™ Patient Control Unit (PCU) provides the vacuum necessary for securing the mouthpi
• 04056719001360: The FRAXION™ Frontpiece is attached to the FRAXION™ Frame in order to set-up the patient wit