LUTONIX® Drug Coated Balloon

Basic Information

• Brand Name: LUTONIX® Drug Coated Balloon
• Primary DI: 00801741177262
• Version / Model: LX1810041204F
• Catalog Number: LX1810041204F
• Company Name: LUTONIX, INC.
• Labeler DUNS: 946734808
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-29
• Public Version: 3
• Public Version Date: 2019-09-04
• Public Version Status: Update
• Public Device Record Key: 6bc0e093-7b9e-44fd-a0dc-d5ab54463182

Device Description

LUTONIX® 018 Drug Coated Balloon PTA Catheter 4X120MMX100CM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PRC	Drug-coated peripheral transluminal angioplasty catheter	Unknown		3
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62551	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741177262	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Balloon Diameter, 4 Millimeter
Device Size Text, specify			Catheter Length, 100 Centimeter
Device Size Text, specify			Balloon Length, 120 Millimeter