Home GUDID 00810017490783 Finesse BTK Multicath
Primary DI 00810017490783
Brand Finesse BTK Multicath
Company Summa Therapeutics, LLC
Model FS350201502
Device description PTA-3.5-020-150
Published 2025-03-22
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 KRA Catheter, Continuous Flush LIT Catheter, Angioplasty, Peripheral, Transluminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRA Catheter, Continuous Flush Cardiovascular 2 LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810017490783 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810017490783 00810017490783 810017490783 0810017490783
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 3.5 Millimeter Balloon Length 20 Millimeter Catheter Working Length 150 Centimeter
Regulatory Flags# DUNS number 091414591 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G4533352797GM8M50 PEAK MEDICAL Peak Medical Distribution Inc. KRA 2026-05-27 07640132622690 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01 07640132622706 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01 07640132622157 M-CATH Microcatheter Acrostak (Schweiz) AG KRA 2018-05-15 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
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