| Primary Device ID | 00817701026310 |
| NIH Device Record Key | 183269b3-fe08-44e0-b21c-d4b65acff228 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nextra CH |
| Version Model Number | CH-35M |
| Company DUNS | 192756786 |
| Company Name | Medartis 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00817701026310 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2020-11-11 |
| 00817701026464 | Cannulated Hammertoe Retriever |
| 00817701026389 | Cannulated Hammertoe Mini Instrument Kit |
| 00817701026372 | Cannulated Hammertoe Standard Instrument Kit |
| 00817701026334 | Cannulated Hammertoe Middle 5.0mm |
| 00817701026327 | Cannulated Hammertoe Middle 4.25mm |
| 00817701026310 | Cannulated Hammertoe Middle 3.5mm |
| 00817701026303 | Cannulated Hammertoe Mini Middle 4.25mm |
| 00817701026297 | Cannulated Hammertoe Mini Middle 3.5mm |
| 00817701026280 | Cannulated Hammertoe Mini Middle 2.75mm |
| 00817701026273 | Cannulated Hammertoe Mini Proximal 2.75mm |
| 00817701026266 | Cannulated Hammertoe Proximal 4.2mm |
| 00817701026259 | Cannulated Hammertoe Proximal 3.2mm |