| Primary Device ID | 07290115750065 |
| NIH Device Record Key | d236f331-00c4-438a-9d31-51c7e2b6e0a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 10.5 Arm Guide Screw Kit |
| Version Model Number | KIT1488-01 |
| Catalog Number | MAS3046-01 |
| Company DUNS | 532681590 |
| Company Name | MAZOR ROBOTICS LTD |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290115750065 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290115750065]
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| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-18 |
| Device Publish Date | 2021-11-10 |
| 07290115750065 | KIT1488-01 |
| 07290115752458 | KIT1488-02 |