Chord-X Chordal Sizer CXCS

GUDID 00851788001495

for sizing or configuring chordal replacement prostheses during mitral valve repair

ON-X LIFE TECHNOLOGIES, INC.

Chordae tendinae sizer

• Primary Device ID: 00851788001495
• NIH Device Record Key: dfabd769-0946-4cfe-9ea6-236ceb6f5219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chord-X Chordal Sizer
• Version Model Number: CXCS
• Catalog Number: CXCS
• Company DUNS: 844782318
• Company Name: ON-X LIFE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851788001495 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-20
• Device Publish Date: 2023-10-12

Devices Manufactured by ON-X LIFE TECHNOLOGIES, INC.

• 00851788001495 - Chord-X Chordal Sizer: 2023-10-20 for sizing or configuring chordal replacement prostheses during mitral valve repair
• 00851788001495 - Chord-X Chordal Sizer: 2023-10-20 for sizing or configuring chordal replacement prostheses during mitral valve repair
• 00851788001020 - On-X Heart Valve Instruments: 2023-08-17 Rotator for heart valve size 19. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mo
• 00851788001037 - On-X Heart Valve Instruments: 2023-08-17 Rotator For valve size 21. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobility
• 00851788001044 - On-X Heart Valve Instruments: 2023-08-17 Rotator For valve size 23. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobility
• 00851788001051 - On-X Heart Valve Instruments: 2023-08-17 Rotator For valve sizes 25. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobilit
• 00851788001068 - On-X Heart Valve Instruments: 2023-08-17 Aortic Sizers for valve size 19 (Gold).The sizers are used to gauge the resulting tissue annulus diameter after the annulus is p
• 00851788001082 - On-X Heart Valve Instruments: 2023-08-17 Aortic SIzers for valve size 19 (grey). The sizers are used to gauge the resulting tissue annulus diameter after the annulus is
• 00851788001099 - On-X Heart Valve Instruments: 2023-08-17 Aortic Sizers for valve size 21(grey).The sizers are used to gauge the resulting tissue annulus diameter after the annulus is pr