Lutonix 035 Drug Coated Balloon PTA Catheter LX35751260V

GUDID 00801741202575

Lutonix 035 12X60MMx75CM

LUTONIX, INC.

Peripheral angioplasty balloon catheter, drug-coated
Primary Device ID00801741202575
NIH Device Record Keycef271af-b55d-4913-b27b-02db3452dbfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameLutonix 035 Drug Coated Balloon PTA Catheter
Version Model NumberLX35751260V
Catalog NumberLX35751260V
Company DUNS946734808
Company NameLUTONIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)321-4254
Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741202575 [Primary]

FDA Product Code

PRCDrug-coated peripheral transluminal angioplasty catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

Devices Manufactured by LUTONIX, INC.

00801741202575 - Lutonix 035 Drug Coated Balloon PTA Catheter2020-02-11Lutonix 035 12X60MMx75CM
00801741202575 - Lutonix 035 Drug Coated Balloon PTA Catheter2020-02-11 Lutonix 035 12X60MMx75CM
00801741187803 - LUTONIX® Drug Coated Balloon2020-02-10 Lutonix 035 12X60MMX100CM
00801741187766 - LUTONIX® Drug Coated Balloon2020-02-10 Lutonix 035 7X100MMX100CM
00801741187759 - LUTONIX® Drug Coated Balloon2020-02-10 Lutonix 035 7X80MMX100CM
00801741187704 - LUTONIX® Drug Coated Balloon2020-02-10 Lutonix 035 7X100MMX75CM
00801741187698 - LUTONIX® Drug Coated Balloon2020-02-10 Lutonix 035 7X80MMX75CM
00801741187681 - LUTONIX® Drug Coated Balloon2020-02-10 Lutonix 035 12X60MMX40CM
00801741187643 - LUTONIX® Drug Coated Balloon2020-02-10 Lutonix 035 7X100MMX40CM

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