Home GUDID 00815212021749 ShadowForm Marker
Primary DI 00815212021749
Brand ShadowForm Marker
Company Izi Medical Products, LLC
Model SF5003
Published 2016-11-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name KPQ System, Simulation, Radiation Therapy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KPQ System, Simulation, Radiation Therapy Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815212021749 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815212021749 00815212021749 815212021749 0815212021749
GMDN Terms# Term, Definition table Term Definition Radiographic image marker, manual An object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.
Regulatory Flags# DUNS number 933506164 Device count 1 Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00856545006003 Acuity iX Radiation Therapy Simulation System VARIAN MEDICAL SYSTEMS, INC. KPQ 2020-09-20 07540180000238 Clarity® Elekta Solutions AB KPQ 2020-06-19 00856545006010 Varian Acuity with Conebeam Computed Tomography VARIAN MEDICAL SYSTEMS, INC. KPQ 2020-06-04 07540180000221 Clarity® Elekta Solutions AB KPQ 2020-05-22 07540180000214 Clarity® Elekta Solutions AB KPQ 2019-03-27 07540180000207 Clarity® Elekta Ltd KPQ 2018-11-19 00815212022012 IZ Ports Izi Medical Products, LLC KPQ 2017-02-08 00815212022050 ShadowForm Marker Izi Medical Products, LLC KPQ 2017-02-07 00815212022067 ShadowForm marker Izi Medical Products, LLC KPQ 2017-02-07 00815212022074 ShadowForm Marker Izi Medical Products, LLC KPQ 2017-02-07 00815212022111 IZ Ports Izi Medical Products, LLC KPQ 2017-02-02 00815212022128 IZ Ports Izi Medical Products, LLC KPQ 2017-02-02 00815212022135 IZ Ports Izi Medical Products, LLC KPQ 2017-02-02 00815212022142 IZ Ports Izi Medical Products, LLC KPQ 2017-02-02 07540180000184 Clarity® Elekta Ltd KPQ 2017-01-10 00815212021695 ShadowForm Marker Izi Medical Products, LLC KPQ 2016-11-17 00815212021701 ShadowForm Marker Izi Medical Products, LLC KPQ 2016-11-17 00815212021718 ShadowForm Marker Izi Medical Products, LLC KPQ 2016-11-17 00815212021725 ShadowForm Marker Izi Medical Products, LLC KPQ 2016-11-17 00815212021732 ShadowForm Marker Izi Medical Products, LLC KPQ 2016-11-17 07540180000016 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000023 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000030 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000047 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000054 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000061 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000078 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000085 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000092 Clarity® Elekta Solutions AB KPQ 2016-09-23 07540180000108 Clarity® Elekta Solutions AB KPQ 2016-09-23