Home GUDID 10884521197701 superDimension
Primary DI 10884521197701
Brand superDimension
Company Covidien LP
Model SDC10
Device description Fiducial Marker;Coil
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile 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 20884521197708 Package GS1 5 Not in Commercial Distribution 10884521197701 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521197708 20884521197708 10884521197701 10884521197701
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 radiological 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. It is not an electromagnetic or optical spatial marker.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0 Outer Diameter 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry
Regulatory Flags# DUNS number 058614483 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 true Sterilization required before use false 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
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