LUTONIX® Drug Coated Balloon LX35757100V

GUDID 00801741187704

Lutonix 035 7X100MMX75CM

LUTONIX, INC.

Peripheral angioplasty balloon catheter, drug-coated
Primary Device ID00801741187704
NIH Device Record Key803fdd7e-a41b-42f8-a11c-9344d9f74df0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUTONIX® Drug Coated Balloon
Version Model NumberLX35757100V
Catalog NumberLX35757100V
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
GS100801741187704 [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 Date2020-02-10
Device Publish Date2020-01-31

On-Brand Devices [LUTONIX® Drug Coated Balloon]

00801741178740LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x220mm
00801741178733LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 6x220mm
00801741177729LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X60MMX130CM
00801741177712LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX130CM
00801741177705LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX130CM
00801741177699LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX130CM
00801741177682LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX130CM
00801741177675LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X100MMX130CM
00801741177668LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X80MMX130CM
00801741177651LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X60MMX130CM
00801741177644LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX130CM
00801741177637LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX130CM
00801741177620LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX130CM
00801741177613LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX130CM
00801741177606LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X100MMX130CM
00801741177590LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X80MMX130CM
00801741177583LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X60MMX130CM
00801741177576LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X40MMX130CM
00801741177569LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X220MMX130CM
00801741177552LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X150MMX130CM
00801741177545LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX130CM
00801741177538LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X100MMX130CM
00801741177521LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X80MMX130CM
00801741177514LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X60MMX130CM
00801741177507LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X40MMX130CM
00801741177446LUTONIX® 018 Drug Coated Balloon PTA Catheter 7X60MMX100CM
00801741177439LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X40MMX100CM
00801741177422LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX100CM
00801741177415LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X150MMX100CM
00801741177408LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX100CM
00801741177392LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X100MMX100CM
00801741177385LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X80MMX100CM
00801741177378LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X60MMX100CM
00801741177361LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X40MMX100CM
00801741177354LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X220MMX100CM
00801741177347LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X150MMX100CM
00801741177330LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X120MMX100CM
00801741177323LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X100MMX100CM
00801741177316LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX100CM
00801741177309LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX100CM
00801741177293LUTONIX® 018 Drug Coated Balloon PTA Catheter, 5X40MMX100CM
00801741177286LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X220MMX100CM
00801741177279LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X150MMX100CM
00801741177262LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX100CM
00801741177255LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X100MMX100CM
00801741177248LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X80MMX100CM
00801741177231LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X60MMX100CM
00801741177224LUTONIX® 018 Drug Coated Balloon PTA Catheter, 4X40MMX100CM
00801741163470Lutonix 035 DCB, 7mm x 220mm x 130cm, 5F
00801741163463Lutonix 035 DCB, 7mm x 150mm x 130cm, 5F

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