| Primary Device ID | 10885862628954 |
| NIH Device Record Key | 44597b95-5999-4d3f-b94c-00d5d6800b09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXACTECHGPS |
| Version Model Number | I00031 |
| Catalog Number | I00031 |
| Company DUNS | 157565946 |
| Company Name | Exactech, 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 | false |
| Serial Number | true |
| 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 | 10885862628954 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-15 |
| Device Publish Date | 2024-04-05 |
| 10885862607195 | Diamond Tracker2 G |
| 10885862607188 | Diamond Tracker2 T |
| 10885862607171 | Diamond Tracker2 F |
| 10885862607164 | Probe Tracker2 P |
| 10885862625601 | Mounting Arm – Upper Part 4 positions |
| 10885862632715 | Station V3 Disposable Kit |
| 10885862628961 | Station V3 Carrying Case |
| 10885862628954 | Station V3 Power Supply |
| 10885862628947 | Station V3 |