| Primary Device ID | 00887868523106 |
| NIH Device Record Key | 7c1e6d35-2e3b-4d4c-b1eb-4afaa45a3fc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE Planner Hip |
| Version Model Number | CG200 |
| Catalog Number | CG200 |
| Company DUNS | 205670032 |
| Company Name | Orthosoft Inc |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868523106 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-05 |
| Device Publish Date | 2021-07-28 |
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| 00887868557910 - ROSA® Shoulder | 2024-03-14 |
| 00887868558078 - ROSA® Shoulder | 2024-03-14 |
| 00887868558092 - ROSA® Shoulder | 2024-03-14 |