| Primary Device ID | 00840097522708 |
| NIH Device Record Key | c7ca6faf-d1c8-45d9-b7d1-6a5b19abd3e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | restor3d Guidewire |
| Version Model Number | 6202-165 |
| Company DUNS | 080819836 |
| Company Name | Restor3d, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840097522708 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-30 |
| Device Publish Date | 2025-05-22 |
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| 00840097512075 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Humeral Cut Protector - Size M |
| 00840097512082 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Reamer - Humeral Metaphysis -Small |
| 00840097512099 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Inserter – Humeral Stem |
| 00840097512464 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Humeral Cut Guide |
| 00840097512471 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Tommy Bar |
| 00840097512488 - restor3d Veritas rTSA Instrumentation | 2025-08-11 Cartilage Scraper |