| 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 |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com | |
| Phone | 15123398039 |
| onx@onxlti.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851788001495 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-20 |
| Device Publish Date | 2023-10-12 |
| 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 |