Home GUDID 00850034171005 Solus Gold™ Embolization Device
Primary DI 00850034171005
Brand Solus Gold™ Embolization Device
Company Artio Medical, Inc
Model SG30
Catalog number SG30
Device description Implant and delivery system for vascular embolization
Published 2022-08-31
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KRD Device, Vascular, For Promoting Embolization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRD Device, Vascular, For Promoting Embolization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850034171005 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 00850034171005 00850034171005 850034171005 0850034171005
GMDN Terms# Term, Definition table Term Definition Non-neurovascular embolization plug, metallic A non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.
Regulatory Flags# DUNS number 079301767 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850034171012 Solus Gold™ Embolization Device SG35 SG35 2022-08-31 00850034171029 Solus Gold™ Embolization Device SG40 SG40 2022-08-31 00850034171036 Solus Gold™ Embolization Device SG45 SG45 2022-08-31 00850034171043 Solus Gold™ Embolization Device SG50 SG50 2022-08-31 00850034171050 Solus Gold™ Embolization Device SG55 SG55 2022-08-31 00850034171067 Solus Gold™ Embolization Device SG60 SG60 2022-08-31
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