Fraxion™
GUDID 04056719002084
The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It
Medical Intelligence Medizintechnik GmbH
Stereotactic radiosurgical/radiotherapy arch head frame| Primary Device ID | 04056719002084 |
| NIH Device Record Key | cefbeda1-f92a-49d6-a5d8-30f539457105 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fraxion™ |
| Version Model Number | P10106-302 |
| Company DUNS | 314546664 |
| Company Name | Medical Intelligence Medizintechnik GmbH |
| Device Count | 10 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056719002084 [Primary] |
| GS1 | 04056719002183 [Unit of Use] |
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-29 |
| Device Publish Date | 2018-10-29 |
On-Brand Devices [Fraxion™ ]
| 04056719002084 | The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuri |
| 04056719002077 | The Fraxion™ Thermoplastic Mask Nose (10pcs) is affixed to the Fraxion Headrest assuring safe |
| 04056719002060 | The Fraxion™ Thermoplastic Mask Head (10 pcs) is affixed to the Fraxion Headrest assuring safe |
Trademark Results [Fraxion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FRAXION 98024708 not registered Live/Pending |
Randolph & Main Capital Group, LLC 2023-06-02 |
 FRAXION 88427186 not registered Live/Pending |
Roman PBS Acquisition Co LLC 2019-05-13 |
 FRAXION 86540915 4961311 Live/Registered |
Lucifer Lighting Company 2015-02-20 |
 FRAXION 76284634 not registered Dead/Abandoned |
IXchange Technology Holdings Limited 2001-07-16 |
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