| Primary Device ID | 04056481146337 |
| NIH Device Record Key | aee0b65f-202f-45fe-8db5-5737df51a651 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alignment Software Cranial with LITT |
| Version Model Number | 2.1 |
| Company DUNS | 314482980 |
| Company Name | Brainlab AG |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 04056481146337 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-04 |
| Device Publish Date | 2025-02-24 |
| 04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm | 2025-03-04 |
| 04056481145637 - Alignment Guide Tube Cranial 4.9 mm / 8.0 mm | 2025-03-04 |
| 04056481145903 - Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm | 2025-03-04 |
| 04056481145910 - Drill Bit Cranial 4.5 mm /4.9 mm | 2025-03-04 |
| 04056481145927 - Drill Depth Stop Cranial 4.9 mm | 2025-03-04 |
| 04056481146047 - Cirq Robotic Tracking Array 10.0 | 2025-03-04 |
| 04056481146337 - Alignment Software Cranial with LITT | 2025-03-04 |
| 04056481146337 - Alignment Software Cranial with LITT | 2025-03-04 |
| 04056481146719 - Sterilization Tray Cirq® Robotic Alignment LITT | 2025-03-04 |