Home GUDID 05744002210016 BioXmark
Primary DI 05744002210016
Brand BioXmark
Company Nanovi A/S
Model 11210590
Catalog number 11210590
Device description Phase-Changing Fiducial Marker
Published 2024-05-08
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name QUV Phase-Changing Fiducial Marker for Radiation Therapy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QUV Phase-Changing Fiducial Marker For Radiation Therapy Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05744002210016 Package GS1 5 In Commercial Distribution 05744002210009 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05744002210016 05744002210016 5744002210016 05744002210009 05744002210009 5744002210009
GMDN Terms# Term, Definition table Term Definition Radiological image marker, implantable A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep Away from Sunlight Storage Environment Temperature 2 Degrees Celsius 25 Degrees Celsius
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 305392394 Device count 1 DM exempt false 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05744002210009 BioXmark 11210590 11210590 2024-05-08
Other Devices Sharing Product Codes# 
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