Lutonix 035 Drug Coated Balloon PTA Catheter LX35751260V

GUDID 00801741202575

Lutonix 035 12X60MMx75CM

LUTONIX, INC.

Peripheral angioplasty balloon catheter, drug-coated

• Primary Device ID: 00801741202575
• NIH Device Record Key: cef271af-b55d-4913-b27b-02db3452dbfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lutonix 035 Drug Coated Balloon PTA Catheter
• Version Model Number: LX35751260V
• Catalog Number: LX35751260V
• Company DUNS: 946734808
• Company Name: LUTONIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)321-4254
• Email: medical.services@crbard.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741202575 [Primary]

FDA Product Code

• PRC: Drug-coated peripheral transluminal angioplasty catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

Devices Manufactured by LUTONIX, INC.

• 00801741202575 - Lutonix 035 Drug Coated Balloon PTA Catheter: 2020-02-11Lutonix 035 12X60MMx75CM
• 00801741202575 - Lutonix 035 Drug Coated Balloon PTA Catheter: 2020-02-11 Lutonix 035 12X60MMx75CM
• 00801741187636 - LUTONIX® Drug Coated Balloon: 2020-02-10 Lutonix 035 7X80MMX40CM
• 00801741187643 - LUTONIX® Drug Coated Balloon: 2020-02-10 Lutonix 035 7X100MMX40CM
• 00801741187681 - LUTONIX® Drug Coated Balloon: 2020-02-10 Lutonix 035 12X60MMX40CM
• 00801741187698 - LUTONIX® Drug Coated Balloon: 2020-02-10 Lutonix 035 7X80MMX75CM
• 00801741187704 - LUTONIX® Drug Coated Balloon: 2020-02-10 Lutonix 035 7X100MMX75CM
• 00801741187759 - LUTONIX® Drug Coated Balloon: 2020-02-10 Lutonix 035 7X80MMX100CM
• 00801741187766 - LUTONIX® Drug Coated Balloon: 2020-02-10 Lutonix 035 7X100MMX100CM