| Primary Device ID | 00859503006107 |
| NIH Device Record Key | c6c67dcb-0ee3-4060-a283-7300ca925791 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUKE Arm |
| Version Model Number | LU-10522-XX2 |
| Company DUNS | 080216821 |
| Company Name | MOBIUS BIONICS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 00859503006107 [Primary] |
| PAE | Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-21 |
| 00859503006107 | ARM, SHOULDER, LEFT, W/O BATTERY |
| 00859503006091 | ARM, SHOULDER, LEFT, W/BATTERY |
| 00859503006084 | ARM, SHOULDER, RIGHT, W/O BATTERY |
| 00859503006077 | ARM, SHOULDER, RIGHT, W/BATTERY |
| 00859503006060 | ARM, HUMERAL, LEFT, W/O BATTERY |
| 00859503006053 | ARM, HUMERAL, LEFT, W/BATTERY |
| 00859503006046 | ARM, HUMERAL, RIGHT, W/O BATTERY |
| 00859503006039 | ARM, HUMERAL, RIGHT, W/BATTERY |
| 00859503006022 | ARM, RADIAL, LEFT-HANDED |
| 00859503006015 | ARM, RADIAL, RIGHT-HANDED |