| Primary Device ID | 07613252133537 |
| NIH Device Record Key | 5d774048-211b-4472-b87e-b27a7e511e05 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5444-0-100 |
| Catalog Number | 5444-0-100 |
| 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 | true |
| 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 | 07613252133537 [Primary] |
| KKY | MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
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| 07613327404876 - INSTRUMENT | 2023-11-10 Triathlon Pro Femoral Trial |
| 07613327404883 - INSTRUMENT | 2023-11-10 Triathlon Pro PS Anterior Bushing |
| 07613327404890 - INSTRUMENT | 2023-11-10 Triathlon Pro PS Anterior Bushing |
| 07613327404906 - INSTRUMENT | 2023-11-10 Triathlon Pro Modular PS Box Trial |
| 07613327404913 - INSTRUMENT | 2023-11-10 Triathlon Pro PS Box Cut Protector |
| 07613327404920 - INSTRUMENT | 2023-11-10 Triathlon Pro Modular PS Box Trial |