Home GUDID 06942265515216 Parafleet SC 018 PTA Balloon Dilatation Catheter
Primary DI 06942265515216
Brand Parafleet SC 018 PTA Balloon Dilatation Catheter
Company BrosMed Medical Co.,Ltd.
Model rev 01
Catalog number F18-045220-200
Published 2025-04-16
Public version status Update
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 06942265515216 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06942265515216 06942265515216 6942265515216
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 421318800 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06941466829177 Balloon Inflation Device rev 01 BM-BID-II30 2026-05-13 06942265520807 Parafleet SC 035 PTA Balloon Dilatation Catheter rev 02 F35-060200-200 2025-05-13 06942265502018 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-035300-090 2025-05-09 06942265502025 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040015-090 2025-05-09 06942265502032 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040020-090 2025-05-09 06942265502049 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040025-090 2025-05-09 06942265502056 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040030-090 2025-05-09 06942265502063 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040040-090 2025-05-09 06942265502070 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040060-090 2025-05-09 06942265502087 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040080-090 2025-05-09 06942265502094 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040100-090 2025-05-09 06942265502100 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040120-090 2025-05-09 06942265502117 Parafleet SC 014PTA Balloon Dilatation Catheter rev 02 F14-040150-090 2025-05-09 06942265502124 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040200-090 2025-05-09 06942265502131 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040220-090 2025-05-09 06942265502148 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-040250-090 2025-05-09 06942265502155 F14-040300-090 rev 01 F14-040300-090 2025-05-09 06942265502162 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-045015-090 2025-05-09 06942265502179 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-045020-090 2025-05-09 06942265502186 Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02 F14-045025-090 2025-05-09
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