| Primary Device ID | 10841291107170 |
| NIH Device Record Key | 260ddb3d-ad4c-41e2-8516-fb529c225025 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A&E Medical / SternaLock® XP Rigid Fixation System |
| Version Model Number | 73-1195 |
| Company DUNS | 173770868 |
| Company Name | A & E MEDICAL CORPORATION |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841291107170 [Primary] |
| HRS | Plate, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-20 |
| Device Publish Date | 2022-01-12 |
| 10841291105794 - Sternal Cable System | 2025-04-29 SS TWO PACK STERNAL CRIMPS |
| 10841291105817 - Sternal Cable System | 2025-04-29 CABLE CUTTER |
| 10841291105824 - Sternal Cable System | 2025-04-29 SS REVERSE CUTTING NEEDLE, 4 CABLES PER POUCH |
| 10841291105831 - Sternal Cable System | 2025-04-29 SS REVERSE CUTTING NEEDLE, 1 CABLE PER POUCH |
| 10841291105855 - Sternal Cable System | 2025-04-29 SS TAPERED CUTTING NEEDLE, 4 CABLES PER POUCH |
| 10841291105862 - Sternal Cable System | 2025-04-29 SS TAPERED CUTTING NEEDLE, 1 CABLE PER POUCH |
| 10841291105893 - Sternal Cable System | 2025-04-29 SS CUTTING EDGE NEEDLE, 4 CABLES PER POUCH |
| 10841291105909 - Sternal Cable System | 2025-04-29 SS CUTTING EDGE NEEDLE, 3 CABLES PER POUCH |