| Primary Device ID | 00851707004361 |
| NIH Device Record Key | 6ffffa0e-cedc-453d-bddb-9d3dd9cb823b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RECELL GO mini |
| Version Model Number | AVRL0105 |
| Company DUNS | 026723570 |
| Company Name | AVITA MEDICAL AMERICAS, LLC |
| 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 | 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 | 00851707004361 [Primary] |
| QCZ | Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-30 |
| Device Publish Date | 2025-01-22 |
| 00851707004361 - RECELL GO mini | 2025-01-30RECELL GO mini Autologous Cell Harvesting Device (Preparation Kit) |
| 00851707004361 - RECELL GO mini | 2025-01-30 RECELL GO mini Autologous Cell Harvesting Device (Preparation Kit) |
| 00851707004279 - RECELL GO | 2024-06-07 RECELL GO Autologous Cell Harvesting Device (Processing Device) |
| 00851707004286 - RECELL GO | 2024-06-07 RECELL GO Autologous Cell Harvesting Device (Preparation Kit) |
| 00851707004262 - RECELL | 2023-07-13 RECELL Autologous Cell Harvesting Device |
| 00851707004200 - RECELL | 2022-05-03 RECELL Autologous Cell Harvesting Device |
| 00851707004149 - RECELL | 2018-11-26 RECELL Autologous Cell Harvesting Device |