Home GUDID 30815112021505
E-Z-Mark
Primary DI 30815112021505
Brand E-Z-Mark
Company Bracco Diagnostics Inc.
Model 901003
Catalog number 901003
Device description Marker
Published 2026-01-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Product Codes# Code, Name table Code Name JAC System, X-Ray, Film Marking, Radiographic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JAC System, X-Ray, Film Marking, Radiographic Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50815112021509 Package GS1 60 In Commercial Distribution 30815112021505 Primary GS1 0 00815112021504 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 50815112021509 50815112021509 30815112021505 30815112021505 00815112021504 00815112021504 815112021504 0815112021504
GMDN Terms# Term, Definition table Term Definition Radiological image marker, noninvasive, single-use A non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker or clip, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a single-use device.
Regulatory Flags# DUNS number 849234661 Device count 250 Premarket exempt true Lot or batch true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10815112020214 Fast Find Grid: Disposable CT Biopsy Grid 600001 600001 2016-09-19 10815112021167 Rounded Flexi Tip Adult Enema Tip 901301 901301 2023-05-25 10815112021181 Miller Enema Air Tip with Non-Latex Retention Cuff 901201 901201 2023-05-25 10815112021198 Miller Enema Air Tip with Retention Cuff 901202 901202 2023-05-25 30815112021703 Two Tank Shuttle Valve System 710602 710602 2025-06-30 30815112021710 DIN 477 High Pressure Hose for CO2 390513 390513 2025-06-30 30815112021291 High Pressure Hose and Yoke 710603 710603 2023-08-31 10815112021174 Enema Kit: Empty Enema Bag Delivery System 900302 900302 2023-05-25 10815112021204 18 French Pediatric Flexi Tip 901308 901308 2023-05-25 30815112020805 High Pressure DISS Hose For CO2 710604 710604 2016-09-19 30815112020782 Two Tank Shuttle Valve System 710602 710602 2016-09-19 10815112020535 E-Z-GEL UltraSound Gel 601001 601001 2016-09-23 10815112020542 E-Z-SCAN Low Viscosity UltraSound Gel 601002 601002 2016-09-23 10815112020559 E-Z-SCAN Low Viscosity UltraSound Gel 601003 601003 2016-09-23 10815112020566 E-Z-GEL UltraSound Gel 601004 601004 2016-09-23 10815112021402 E-Z-GEL UltraSound Gel 601001 601001 2025-05-16 10815112021419 E-Z-SCAN Low Viscosity UltraSound Gel 601002 601002 2025-05-16 10815112021426 E-Z-SCAN Low Viscosity UltraSound Gel 601003 601003 2025-05-16 10815112021433 E-Z-GEL UltraSound Gel 601004 601004 2025-05-16 10815112020856 """Y"" Connector with Tubing" 900402 900402 2016-09-19
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