Home GUDID B365501260 Cranial Stereotactic Localizer Frame
Primary DI B365501260
Brand Cranial Stereotactic Localizer Frame
Company Aktina Corp.
Model 50-126
Published 2021-05-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 B365501260 Primary HIBCC 0
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 787178920 Device count 1 Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B365112200 Head and Neck Overlay with Shoulder Restraints 11-220 2016-09-24 B365805000 Navigator CS 80-500 2016-09-24 B3658080000 isoPoint Validation Software 80-800 2024-07-01 B365601900 Belly Compression Arch Kit 60-190 2016-09-24 B365603100 Respiratory Belt with Bladder, Small 60-310 2016-09-28 B365603110 Respiratory Belt with Bladder, Medium 60-311 2016-09-28 B365603120 Respiratory Belt with Bladder, Large 60-312 2016-09-28 B365503710 Transport Cart, SRS Cones 50-371 2021-05-21 B365503720 Bar Code Reader Kit 50-372 2021-05-21 B365503750 Film Holder 50-375 2021-05-21 B365503022100 Circular Small Field Cone Insert, Elekta, 21mm 50-302-210 2016-10-04 B365503022200 Circular Small Field Cone Insert, Elekta, 22mm 50-302-220 2016-10-04 B365503022300 Circular Small Field Cone Insert, Elekta, 23mm 50-302-230 2016-10-04 B365503022400 Circular Small Field Cone Insert, Elekta, 24mm 50-302-240 2016-10-04 B365503022500 Circular Small Field Cone Insert, Elekta, 25mm 50-302-250 2016-10-04 B365503022600 Circular Small Field Cone Insert, Elekta, 26mm 50-302-260 2016-10-04 B365503022700 Circular Small Field Cone Insert, Elekta, 27mm 50-302-270 2016-10-04 B365503022800 Circular Small Field Cone Insert, Elekta, 28mm 50-302-280 2016-10-04 B365503022900 Circular Small Field Cone Insert, Elekta, 29mm 50-302-290 2016-10-04 B365503023000 Circular Small Field Cone Insert, Elekta, 30mm 50-302-300 2016-10-04
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