| Primary Device ID | 07640164849621 |
| NIH Device Record Key | bd47ae14-3e0c-448c-9831-1af3d3922ed7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | icotec Pedicle System 6.0, Screw, Ti, Polyax., Fen., Ø 8.5 x 60 mm |
| Version Model Number | 16-6022-98560 |
| 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 |
| Phone | +41717570000 |
| info@icotec.ch | |
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| Phone | +41717570000 |
| info@icotec.ch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640164849621 [Primary] |
| PML | Bone Cement, Posterior Screw Augmentation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-04 |
| Device Publish Date | 2020-10-27 |
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