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 ID04056719002084
NIH Device Record Keycefbeda1-f92a-49d6-a5d8-30f539457105
Commercial Distribution StatusIn Commercial Distribution
Brand NameFraxion™
Version Model NumberP10106-302
Company DUNS314546664
Company NameMedical Intelligence Medizintechnik GmbH
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
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Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104056719002084 [Primary]
GS104056719002183 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-29
Device Publish Date2018-10-29

On-Brand Devices [Fraxion™ ]

04056719002084The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuri
04056719002077The Fraxion™ Thermoplastic Mask Nose (10pcs) is affixed to the Fraxion Headrest assuring safe
04056719002060The 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
FRAXION
98024708 not registered Live/Pending
Randolph & Main Capital Group, LLC
2023-06-02
FRAXION
FRAXION
88427186 not registered Live/Pending
Roman PBS Acquisition Co LLC
2019-05-13
FRAXION
FRAXION
86540915 4961311 Live/Registered
Lucifer Lighting Company
2015-02-20
FRAXION
FRAXION
76284634 not registered Dead/Abandoned
IXchange Technology Holdings Limited
2001-07-16

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