Home GUDID 00801741177217 LUTONIX® Drug Coated Balloon
Primary DI 00801741177217
Brand LUTONIX® Drug Coated Balloon
Company LUTONIX, INC.
Model LX187572205F
Catalog number LX187572205F
Device description Lutonix 018 7X220MMX75CM
Published 2019-10-09
Public version status Update
Distribution status Not 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 ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter PRC Drug-coated peripheral transluminal angioplasty catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown 3 PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00801741177217 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 00801741177217 00801741177217 801741177217 0801741177217
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, drug-coated A sterile, 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, and to simultaneously release a drug intended to inhibit restenosis; 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. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 946734808 Device count 1 Combination product true 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 00801741187704 LUTONIX® Drug Coated Balloon LX35757100V LX35757100V 2020-01-31 00801741163432 LUTONIX® Drug Coated Balloon LX351307805F LX351307805F 2018-09-14 00801741177422 LUTONIX® Drug Coated Balloon LX1810062205F LX1810062205F 2019-01-11 00801741187698 LUTONIX® Drug Coated Balloon LX3575780V LX3575780V 2020-01-31 00801741184673 LUTONIX® Drug Coated Balloon LX1810043005F LX1810043005F 2020-01-28 00801741184697 LUTONIX® Drug Coated Balloon LX1810063005F LX1810063005F 2020-01-29 00801741123320 LUTONIX® Drug Coated Balloon LX351307605F LX351307605F 2016-04-25 00801741135330 LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35754100V LX35754100V 2017-08-28 00801741135378 LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35755100V LX35755100V 2017-08-28 00801741135385 LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575640V LX3575640V 2017-08-28 00801741135392 LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575660V LX3575660V 2017-08-28 00801741135415 LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX35756100V LX35756100V 2017-08-28 00801741135439 LUTONIX ® 035 Drug Coated Balloon PTA Catheter LX3575760V LX3575760V 2017-08-28 00801741163456 LUTONIX® Drug Coated Balloon LX3513071205F LX3513071205F 2018-09-14 00801741163470 LUTONIX® Drug Coated Balloon LX3513072205F LX3513072205F 2018-09-14 00801741177279 LUTONIX® Drug Coated Balloon LX1810041504F LX1810041504F 2019-01-10 00801741177286 LUTONIX® Drug Coated Balloon LX1810042204F LX1810042204F 2019-01-11 00801741177316 LUTONIX® Drug Coated Balloon LX181005805F LX181005805F 2019-01-29 00801741177323 LUTONIX® Drug Coated Balloon LX1810051005F LX1810051005F 2019-01-29 00801741177330 LUTONIX® Drug Coated Balloon LX1810051205F LX1810051205F 2019-01-29
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