AccessGUDID - DEVICE: Fraxion (04056719001575)

GUDID

Device Identifier (DI) Information

Brand Name: Fraxion
Version or Model: P10106-106
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P10106-106
Company Name: 3C-Medical Intelligence GmbH

Primary DI Number: 04056719001575
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314546664 *Terms of Use

Device Description: Fraxion™ Vacuum Pump provides vacuum to fix the Fraxion™ Mouthpiece and to evacuate the Fraxion™ Vacuum Cushion.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61128	Stereotactic radiosurgical/radiotherapy arch head frame	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112210	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c85d67c-cf8b-4b86-ae00-67bcc6b661a2
Public Version Date: December 15, 2023
Public Version Number: 7
DI Record Publish Date: November 17, 2017