| Primary Device ID | 06429811532076 |
| NIH Device Record Key | 78661d95-ea1b-47f5-b256-49d63f683e43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgify Halo | 4.0 mm | Extendable |
| Version Model Number | 40.000.SEE.H1 |
| Company DUNS | 368510617 |
| Company Name | Surgify Medical Oy |
| 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 | 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 | 06429811532076 [Primary] |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-26 |
| Device Publish Date | 2025-06-18 |
| 06429811532069 - Surgify Halo | 4.0 mm | Short | 2025-06-26 |
| 06429811532076 - Surgify Halo | 4.0 mm | Extendable | 2025-06-26 |
| 06429811532076 - Surgify Halo | 4.0 mm | Extendable | 2025-06-26 |
| 06429811532083 - Surgify Halo | 4.0 mm | Long | 2025-06-26 |
| 06429811532090 - Surgify Halo | 5.4 mm | Short | 2025-04-10 |
| 06429811532106 - Surgify Halo | 5.4 mm | Long | 2025-04-10 |
| 06429811532120 - Surgify Halo | 5.4 mm | Medium | 2025-04-10 |
| 06429811532137 - Surgify Halo | 5.4 mm | Long | 2025-04-10 |
| 06429830116998 - Surgify Halo | 5.4 mm | Extendable | 2025-04-10 |