NIRxcell™ CoCr Coronary Stent on RX System

GUDID 07290107012973

MEDINOL LTD.

Bare-metal coronary artery stent

• Primary Device ID: 07290107012973
• NIH Device Record Key: 9fa9d53c-74ae-4995-b457-3df8f1e01bd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIRxcell™ CoCr Coronary Stent on RX System
• Version Model Number: NXL35015US
• Company DUNS: 600593800
• Company Name: MEDINOL LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 1-800-477-5801
• Email: xxx@xxx.xxx

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107012973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110004

FDA Product Code

• MAF: Stent, Coronary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-05-09

On-Brand Devices [NIRxcell™ CoCr Coronary Stent on RX System]

• 07290107012980: NXL40015US
• 07290107012973: NXL35015US
• 07290107012966: NXL30015US
• 07290107012959: NXL27515US
• 07290107012942: NXL25015US
• 07290107010757: NXL25008US