Home GUDID 04056719001858 HeadFIX
Primary DI 04056719001858
Brand HeadFIX
Company 3C-Medical Intelligence GmbH
Model P10103-603
Catalog number P10103-603
Device description The HeadFIX® Mouthpiece Medium is affixed to the HeadFIX Angulating Fixation Set assuring safeimmobilization and precise (re-) positioning.
Published 2016-08-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name IYE Accelerator, Linear, Medical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYE Accelerator, Linear, Medical Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04056719000431 Package GS1 10 Not in Commercial Distribution 04056719001858 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04056719000431 04056719000431 4056719000431 04056719001858 04056719001858 4056719001858
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 314546664 Device count 1 DM exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840277411815 Gold Marker RIVERPOINT MEDICAL, LLC IYE 2026-03-11 00850002461343 BiomarC® Carbon Medical Technologies, Inc. IYE 2024-07-23 00850002461350 Carbon Bright ® Carbon Medical Technologies, Inc. IYE 2024-07-23 00850016008176 VeraForm Viscus Biologics LLC IYE 2024-01-16 07340145700421 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700445 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700506 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700582 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700643 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700667 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701060 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701084 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701107 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701121 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701145 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701169 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701183 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701206 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701220 Gold Anchor Naslund Medical AB IYE 2023-01-23 B887001062 X-MARK Ultra Izi Medical Products, LLC IYE 2022-07-18 B887001067 X-MARK Ultra Izi Medical Products, LLC IYE 2022-07-18 B8870010010 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010020 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010030 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010070 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010080 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010090 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010210 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010220 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010230 X-MARK Izi Medical Products, LLC IYE 2022-06-17