NIRxcell CoCr Coronary Stent on RX System

GUDID 07290107011051

MEDINOL LTD.

Bare-metal coronary artery stent

• Primary Device ID: 07290107011051
• NIH Device Record Key: 915d66c1-9c0e-41cf-b823-62a9bb5a70ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIRxcell CoCr Coronary Stent on RX System
• Version Model Number: NXL40028US
• 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: 4 Millimeter
• Outer Diameter: 4 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	07290107011051 [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: 2014-10-01

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

• 07290107011068: NXL40033US
• 07290107011051: NXL40028US
• 07290107011044: NXL40024US
• 07290107011037: NXL40020US
• 07290107011020: NXL40017US
• 07290107011013: NXL40012US
• 07290107011006: NXL40008US
• 07290107010993: NXL35033US
• 07290107010986: NXL35028US
• 07290107010979: NXL35024US
• 07290107010962: NXL35020US
• 07290107010955: NXL35017US
• 07290107010948: NXL35012US
• 07290107010931: NXL35008US
• 07290107010924: NXL30033US
• 07290107010917: NXL30028US
• 07290107010900: NXL30024US
• 07290107010894: NXL30020US
• 07290107010887: NXL30017US
• 07290107010870: NXL30012US
• 07290107010863: NXL30008US
• 07290107010856: NXL27533US
• 07290107010849: NXL27528US
• 07290107010832: NXL27524US
• 07290107010825: NXL27520US
• 07290107010818: NXL27517US
• 07290107010801: NXL27512US
• 07290107010795: NXL27508US
• 07290107010788: NXL25020US
• 07290107010771: NXL25017US
• 07290107010764: NXL25012US