Home GUDID 06934955937149
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
Primary DI 06934955937149
Brand JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
Company OrbusNeich Medical (ShenZhen) Co., Ltd.
Model 5940-240-12
Catalog number 5940-240-12
Device description Percutaneous Transluminal Angioplasty Balloon Catheter
Published 2024-07-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true
Product Codes# Code, Name table Code Name LIT Catheter, Angioplasty, Peripheral, Transluminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06934955937149 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06934955937149 06934955937149 6934955937149
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Regulatory Flags# DUNS number 530923226 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06934955934742 COREPASS Modular Microcatheter 8425-150-02 2025-03-20 06934955934728 COREPASS Modular Microcatheter 8422-150-02 2025-03-01 06934955934735 COREPASS Modular Microcatheter 8425-135-02 2025-03-01 06934955934711 COREPASS Modular Microcatheter 8422-135-02 2025-03-01 06934955916960 Teleport XT Microcatheter 7321-090-01 7321-090-01 2024-01-25 06934955916977 Teleport XT Microcatheter 7321-135-01 7321-135-01 2024-01-25 06934955916984 Teleport XT Microcatheter 7321-150-01 7321-150-01 2024-01-25 06934955915963 Teleport XT Microcatheter 7321-090-01 2025-03-01 06934955915970 Teleport XT Microcatheter 7321-135-01 2025-03-01 06934955915987 Teleport XT Microcatheter 7321-150-01 2025-03-01 06934955979019 Sapphire ULTRA Coronary Dilatation Catheter 7910-005-11 2025-02-20 06934955979026 Sapphire ULTRA Coronary Dilatation Catheter 7910-008-11 2025-02-20 06934955979033 Sapphire ULTRA Coronary Dilatation Catheter 7910-010-11 2025-02-20 06934955979040 Sapphire ULTRA Coronary Dilatation Catheter 7910-015-11 2025-02-20 06934955979057 Sapphire ULTRA Coronary Dilatation Catheter 7912-005-11 2025-02-20 06934955979064 Sapphire ULTRA Coronary Dilatation Catheter 7912-008-11 2025-02-20 06934955979071 Sapphire ULTRA Coronary Dilatation Catheter 7912-010-11 2025-02-20 06934955979088 Sapphire ULTRA Coronary Dilatation Catheter 7912-015-11 2025-02-20 06934955979095 Sapphire ULTRA Coronary Dilatation Catheter 7915-010-11 2025-02-20 06934955979101 Sapphire ULTRA Coronary Dilatation Catheter 7915-012-11 2025-02-20
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