LUTONIX ® Drug Coated Balloon LX181007805F

GUDID 00801741177453

Lutonix 018 7X80MMX100CM

LUTONIX, INC.

Peripheral angioplasty balloon catheter, drug-coated

• Primary Device ID: 00801741177453
• NIH Device Record Key: 70c83df5-1b6f-4241-849b-5c02ac27e54c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUTONIX ® Drug Coated Balloon
• Version Model Number: LX181007805F
• Catalog Number: LX181007805F
• 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	00801741177453 [Primary]

FDA Product Code

• ONU: Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-04
• Device Publish Date: 2019-05-30

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• 00801741187759 - LUTONIX® Drug Coated Balloon: 2020-02-10 Lutonix 035 7X80MMX100CM
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