| Primary Device ID | 07640164849614 |
| NIH Device Record Key | 580074b3-09f6-49ce-b46d-d3c6e00254e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | icotec Pedicle System 6.0, Screw, Ti, Polyax., Fen., Ø 8.5 x 55 mm |
| Version Model Number | 16-6022-98555 |
| Company DUNS | 480789465 |
| Company Name | icotec AG |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
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