| Primary Device ID | 08809486292808 |
| NIH Device Record Key | cf3fdc17-64fb-4efb-bf9a-2b7f04a21883 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neobiotech Implant System |
| Version Model Number | IS3H4010P |
| Company DUNS | 688371566 |
| Company Name | Neobiotech. co., ltd |
| 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 | true |
| Manufacturing Date | false |
| 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 |