Home GUDID 06934955960710 Jade PTA Balloon Dilatation Catheter
Primary DI 06934955960710
Brand Jade PTA Balloon Dilatation Catheter
Company OrbusNeich Medical (ShenZhen) Co., Ltd.
Model 604010032
Device description Percutaneous Transluminal Angioplasty (PTA) Catheter
Published 2020-12-25
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 06934955960710 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06934955960710 06934955960710 6934955960710
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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