Home GUDID 00801741031885 Gel Mark Ultra™ Breast Tissue Marker
Primary DI 00801741031885
Brand Gel Mark Ultra™ Breast Tissue Marker
Company SENORX, INC.
Model MK2011
Catalog number MK2011
Device description GEL MARK ULTRA™ Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"
Published 2015-10-01
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 FZP CLIP, IMPLANTABLE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZP Clip, Implantable General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10801741031882 Package GS1 10 Not in Commercial Distribution 00801741031885 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 10801741031882 10801741031882 00801741031885 00801741031885 801741031885 0801741031885
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 Needle Gauge 0
Regulatory Flags# DUNS number 043674543 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 false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00801741031847 Gel Mark Ultra™ Breast Tissue Marker GMU11T GMU11T 2015-10-01 00801741031854 Gel Mark Ultra™ Breast Tissue Marker GMUEC10GSS GMUEC10GSS 2015-10-01 00801741031861 Gel Mark Ultra™ Breast Tissue Marker GMUEC7GSS GMUEC7GSS 2015-10-01 00801741031892 Gel Mark UltraCor® Breast Tissue Marker GMUTC005SS GMUTC005SS 2015-10-01 00801741031908 Gel Mark UltraCor® Breast Tissue Marker GMUTC005T GMUTC005T 2015-10-01 00801741031915 SenoMark® Breast Tissue Marker SMEC10GSS SMEC10GSS 2015-10-01 00801741031922 SenoMark® Breast Tissue Marker SMEC12GSS SMEC12GSS 2015-10-01 00801741031939 SenoMark® Breast Tissue Marker SMEC7GSS SMEC7GSS 2015-10-01 00801741031946 SenoMark® Breast Tissue Marker SMRSU12GT SMRSU12GT 2015-10-01 00801741031953 SenoMark® Breast Tissue Marker SMRSU9GT SMRSU9GT 2015-10-01 00801741031960 SenoMark® Breast Tissue Marker SMSE9GT SMSE9GT 2015-10-01 00801741031977 SenoMark® Breast Tissue Marker SMTEC10G SMTEC10G 2015-10-01 00801741031984 SenoMark® Breast Tissue Marker SMTMT11G SMTMT11G 2015-10-01 00801741031991 SenoMark® Breast Tissue Marker SMTSU9G SMTSU9G 2015-10-01 00801741032141 SenoMark UltraCor™ MRI Breast Tissue Marker SMUCMRI14GSS SMUCMRI14GSS 2015-10-02 00801741032158 SenoMark UltraCor™ MRI Breast Tissue Marker SMUCMRI14GT SMUCMRI14GT 2015-10-02 00801741032165 StarchMark® Breast Tissue Marker STMKEC10GSS STMKEC10GSS 2015-10-02 00801741032172 StarchMark® Breast Tissue Marker STMKEC7GSS STMKEC7GSS 2015-10-02 00801741032189 StarchMark® Breast Tissue Marker STMKMT11GSS STMKMT11GSS 2015-10-02 00801741032196 StarchMark® UltraCor™ Breast Tissue Marker STMK14GSS STMK14GSS 2015-10-02
Other Devices Sharing Product Codes# 
crbard.com