| Primary Device ID | 50690103019242 |
| NIH Device Record Key | 2201995c-df83-4238-9608-71012d2f3695 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DISPOSABLE HANDLE FOR VALVES/SIZERS |
| Version Model Number | 1126 |
| Catalog Number | 1126 |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| 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 | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103019247 [Primary] |
| GS1 | 50690103019242 [Package] Contains: 00690103019247 Package: Case [10 Units] In Commercial Distribution |
| DTI | Sizer, Heart-Valve, Prosthesis |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-28 |
| Device Publish Date | 2024-10-18 |
| 00690103019063 - HEART VALVE HANDLE ACCESSORY | 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV |
| 50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS | 2024-10-28DISPOSABLE HANDLE FOR VALVES/SIZERS |
| 50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS | 2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS |
| 00690103019339 - HEART VALVE ACCESSOR | 2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S |
| 00690103166989 - HEART VALVE ACCESSOR | 2024-10-28 MITRAL SIZER HANDLE |
| 00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 | 2024-10-28 RING HANDLE - EXTENDED 4" |
| 00690103186437 - FLEXIBLE HANDLE | 2024-10-28 FLEXIBLE HANDLE |
| 00690103210132 - MITRIS Handle 1140M | 2024-10-28 11400M valve handle |
| 00690103217773 - Edwards EVOQUE Loading System | 2024-10-11 Edwards EVOQUE Loading System |