| Primary Device ID | 04056481142827 |
| NIH Device Record Key | 1a298037-c977-4981-9026-43a3f342a893 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Loop-X Disposable Sterile Drape Set |
| Version Model Number | 22183-01 |
| Company DUNS | 314482980 |
| Company Name | Brainlab AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | 04056481142827 [Package] Contains: 04056481143299 Package: [5 Units] In Commercial Distribution |
| GS1 | 04056481143299 [Primary] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-20 |
| Device Publish Date | 2021-10-12 |
| 04056481146108 - Hex Screwdriver 4 mm | 2025-08-22 |
| 04056481146528 - Hex Screwdriver 2.5 mm | 2025-08-22 |
| 04056481146672 - Mixed Reality Spine Navigation | 2025-08-08 |
| 04056481145941 - Disposable Loop-X Source Drape (1 Pc) | 2025-08-04 The source drape is intended to sterile cover the source (cone beam) of the Loop-X. |
| 04056481145934 - Disposable Loop-X Detector Drape (1 Pc) | 2025-08-01 Is intended to sterile cover the detector of the Loop-X. |
| 04056481145330 - CRANIAL 4PI HEADREST PLATFORM | 2025-07-04 |
| 04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD | 2025-07-04 |
| 04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.) | 2025-07-04 |