Home GUDID 05391525787497 Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter
Primary DI 05391525787497
Brand Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter
Company CREAGH MEDICAL LIMITED
Model SER18-135-60-220
Device description 018 Advance Serenity 6x220, 135cm
Published 2025-03-14
Public version status New
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
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 05391525787497 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391525787497 05391525787497 5391525787497
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 6 Millimeter Balloon Length 220 Millimeter Catheter Working Length 135 Centimeter
Regulatory Flags# DUNS number 985021909 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 05391525785110 Sublime™ Radial Access Guide Sheath SRA-GS18-5F120 2020-12-07 05391525785127 Sublime™ Radial Access Guide Sheath SRA-GS35-5F120 2020-12-07 05391525785134 Sublime™ Radial Access Guide Sheath SRA-GS18-5F150 2020-12-07 05391525785141 Sublime™ Radial Access Guide Sheath SRA-GS35-5F150 2020-12-07 05391525785158 Sublime™ Radial Access Guide Sheath SRA-GS18-6F120 2020-12-07 05391525785165 Sublime™ Radial Access Guide Sheath SRA-GS35-6F120 2020-12-07 05391525785172 Sublime™ Radial Access Guide Sheath SRA-GS18-6F150 2020-12-07 05391525785189 Sublime™ Radial Access Guide Sheath SRA-GS35-6F150 2020-12-07 05391525787480 Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter SER18-135-50-220 2025-03-14 05391525787503 Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter SER18-135-70-220 2025-03-14 05391525785912 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20020 2021-10-20 05391525785929 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20040 2021-10-20 05391525785936 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20060 2021-10-20 05391525785943 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20080 2021-10-20 05391525785950 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20100 2021-10-20 05391525785967 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20120 2021-10-20 05391525785974 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20150 2021-10-20 05391525785981 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20220 2021-10-20 05391525785998 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-25020 2021-10-20 05391525786001 Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-25040 2021-10-20
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10193489069334 NAMIC MEDLINE INDUSTRIES, INC. LIT 2021-10-28 10193489069341 NAMIC MEDLINE INDUSTRIES, INC. LIT 2021-07-26 20193489087793 Medline MEDLINE INDUSTRIES, INC. LIT 2021-05-12 H965800450750 NAMIC ANGIODYNAMICS, INC. LIT 2020-11-03 00643169843059 Stretch™ Insertion Tool MEDTRONIC, INC. LIT 2018-07-06 H965914003000 NAMIC NAVILYST MEDICAL, INC. LIT 2016-09-21 H965914004000 NAMIC NAVILYST MEDICAL, INC. LIT 2016-09-21 00643169002913 Stretch™ Insertion Tool MEDTRONIC, INC. LIT 2016-07-02 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