| Primary Device ID | 10886982300829 |
| NIH Device Record Key | b2615762-d8ae-48c6-be36-c41dce184d8a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 03.405.000S |
| Catalog Number | 03405000S |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886982300829 [Primary] |
| KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-05-02 |
| Device Publish Date | 2020-06-08 |
| 10886982348142 - NA | 2024-08-05 UNCANNULATED XL XL40 DRIVER |
| 10887587078380 - NA | 2024-08-05 45 DEGREE TIP FLAT RIB FORCEPS, LEFT |
| 10887587078397 - NA | 2024-08-05 90 DEGREE TIP FLAT RIB FORCEPS, LEFT |
| 07612334292100 - NA | 2024-08-02 TRAY FOR REDUCTION AND SCREW INSERTION INSTRUMENTS |
| 07612334292117 - NA | 2024-08-02 TRAY FOR LCP PLATES |
| 07612334292124 - NA | 2024-08-02 SCREW CADDY |
| 07612334292131 - NA | 2024-08-02 TRAY F/WIRE IMPL & INSTRUMENTS |
| 10886982347466 - NA | 2024-08-02 RIGID INSERTION SLEEVE |