| Primary Device ID | 37613327579797 |
| NIH Device Record Key | 0c647c84-7091-40ce-b2d5-d27b67a07bf4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | System12 |
| Version Model Number | C-M112-7-500 |
| Catalog Number | C-M112-7-500 |
| Company DUNS | 058311945 |
| Company Name | Howmedica Osteonics Corp. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | 07613327579802 [Primary] |
| GS1 | 37613327579797 [Package] Contains: 07613327579802 Package: pack [1 Units] In Commercial Distribution |
| GS1 | 57613327579791 [Package] Package: case [1 Units] In Commercial Distribution |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-25 |
| Device Publish Date | 2021-10-15 |
| 07613327597448 - TRIATHLON GOLD | 2025-11-28 CRUCIATE RETAINING FEMORAL |
| 07613327597455 - TRIATHLON GOLD | 2025-11-28 CRUCIATE RETAINING FEMORAL |
| 07613327597509 - TRIATHLON GOLD | 2025-11-28 CRUCIATE RETAINING FEMORAL |
| 07613327597516 - TRIATHLON GOLD | 2025-11-28 CRUCIATE RETAINING FEMORAL |
| 07613327597578 - TRIATHLON GOLD | 2025-11-28 CRUCIATE RETAINING FEMORAL |
| 07613327597585 - TRIATHLON GOLD | 2025-11-28 CRUCIATE RETAINING FEMORAL |
| 07613327597592 - TRIATHLON GOLD | 2025-11-28 CRUCIATE RETAINING FEMORAL |
| 07613327597639 - TRIATHLON GOLD | 2025-11-28 CRUCIATE RETAINING FEMORAL |