Home GUDID 06934599541269 Scoreflex PTA Scoring Balloon Catheter
Primary DI 06934599541269
Brand Scoreflex PTA Scoring Balloon Catheter
Company OrbusNeich Medical (ShenZhen) Co., Ltd.
Model BL620-204CU
Device description Catheter, Percutaneous, Cutting/Scoring
Published 2019-10-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LIT Catheter, Angioplasty, Peripheral, Transluminal PNO Catheter, Percutaneous, Cutting/Scoring
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2 PNO Catheter, Percutaneous, Cutting/Scoring Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06934599541269 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06934599541269 06934599541269 6934599541269
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.
Device Sizes# Type, Value, Unit table Type Value Unit Balloon Diameter 2 Millimeter Balloon Length 20 Millimeter Catheter Length 150 Centimeter Guidewire Diameter 0.018 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in dark, cool, dry place.
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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08033477048772 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049045 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049199 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049212 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049229 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049250 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049281 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049311 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049373 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049434 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049397 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049090 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048727 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048734 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048765 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048796 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048819 REEF HP MEDTRONIC, INC. LIT 2016-06-19
orbusneich.com