Gallant™ PTCA Dilatation Catheter

GUDID 07290107014533

MEDINOL LTD.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 07290107014533
• NIH Device Record Key: 220b21ac-1257-492b-9f05-e3fdd883574f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gallant™ PTCA Dilatation Catheter
• Version Model Number: SCG300R12US
• Company DUNS: 600593800
• Company Name: MEDINOL LTD.
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +972732265727
• Email: contact@medinol.com

Device Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107014533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173581

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-08-15

On-Brand Devices [Gallant™ PTCA Dilatation Catheter]

• 07290107014557: SCG300R30US
• 07290107014540: SCG300R15US
• 07290107014533: SCG300R12US
• 07290107014526: SCG250R30US
• 07290107014519: SCG250R15US
• 07290107014502: SCG250R12US
• 07290107014496: SCG200R30US
• 07290107014489: SCG200R06US