| Primary Device ID | 08809986616432 |
| NIH Device Record Key | 17d3c819-418f-4a87-9fa9-8cb7b0edf591 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMII IMPLANT |
| Version Model Number | 551M5513S |
| Company DUNS | 631169224 |
| Company Name | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |