| Primary Device ID | 04711605991674 |
| NIH Device Record Key | 5875f98c-12c5-48d0-9e07-94bac4f84343 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The OR Company-InsufflatOR Needle |
| Version Model Number | IN-15-4 |
| Company DUNS | 656305567 |
| Company Name | ADVANCED MEDICAL DESIGN 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 | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |