FDA.reportPublic FDA data

Fraxion

Primary DI
04056719001612
Brand
Fraxion
Company
Medical Intelligence Medizintechnik GmbH
Model
P10106-323
Catalog number
P10106-323
Device description
The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112210000FRAXIONMedical Intelligence Medizintechnik GmbH2011-11-22IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056719001612PackageGS110In Commercial Distribution
04056719001780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056719001612040567190016124056719001612
04056719001780040567190017804056719001780

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic radiosurgical/radiotherapy arch head frameA non-sterile device intended to be used to position and immobilize a patient’s head for reproducible positioning during radiation treatment planning, stereotactic radiotherapy (SRT), and stereotactic radiosurgery (SRS), on all parts of the brain, head, and neck. It is in the form of an arched frame to which can be attached various components (e.g., mouthpiece, nasion cushion) that non-invasively contact the patient to serve as points of reference, and which is typically attached to a base plate, couch top, or overlay. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314546664
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056719001605FraxionP10106-322 P10106-322 2016-08-23
04056719000264BodyFIXP10102-305 P10102-305 2016-08-23
04056719000295BodyFIXP10102-309P10102-3092016-08-23
04056719000370HeadFIXP10103-309 P10103-309 2016-08-23
04056719000387HeadFIXP10103-311 P10103-311 2016-08-23
04056719000394HeadFIXP10103-312 P10103-312 2016-08-23
04056719000400HeadFIXP10103-403 P10103-403 2016-08-23
04056719000431HeadFIXP10103-603 P10103-603 2016-08-23
04056719000448HeadFIXP10103-604 P10103-604 2016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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