Chord-X Premeasured Loops and Suture System CXL-30-1812-12

GUDID 00813570020718

Artificial chordal replacement prosthesis

ON-X LIFE TECHNOLOGIES, INC.

Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 00813570020718
• NIH Device Record Key: 992f9211-54c7-4f59-8e21-f47e34bcf0b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chord-X Premeasured Loops and Suture System
• Version Model Number: CXL-30-1812-12
• Catalog Number: CXL-30-1812-12
• Company DUNS: 844782318
• Company Name: ON-X LIFE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com

Device Dimensions

• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter
• Outer Diameter: 0.2245 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813570020312 [Primary]
GS1	00813570020718 [Package]; Contains: 00813570020312; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141060

FDA Product Code

• PAW: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

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: 2019-06-25
• Device Publish Date: 2015-12-01

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