| Primary Device ID | 00817701020158 |
| NIH Device Record Key | 4bfc8d30-dedf-4cb4-87dd-5484854c7296 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arcus Staple System |
| Version Model Number | ARC-1613A |
| Company DUNS | 060783407 |
| Company Name | NEXTREMITY SOLUTIONS, 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 | 00817701020158 [Primary] |
| JDR | Staple, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-26 |
| Device Publish Date | 2016-09-26 |
| 00817701020219 | 20mm X 17mm Arcus Staple Kit |
| 00817701020202 | 16mm X 13mm Arcus Staple Kit |
| 00817701020196 | 13mm X 10mm Arcus Staple Kit |
| 00817701020189 | 10mm X 8mm Arcus Staple Kit |
| 00817701020172 | 8mm X 8mm Arcus Staple Kit |
| 00817701020165 | 20mm X 17mm Arcus Staple Individual Assembly |
| 00817701020158 | 16mm X 13mm Arcus Staple Individual Assembly |
| 00817701020141 | 13mm X 10mm Arcus Staple Individual Assembly |
| 00817701020134 | 10mm X 8mm Arcus Staple Individual Assembly |
| 00817701020127 | 8mm X 8mm Arcus Staple Individual Assembly |
| 00817701020110 | Arcus Staple Sizing Template Kit |