| Primary Device ID | 04907034602193 |
| NIH Device Record Key | 01af94f5-4695-4003-8b57-59532fe0e59e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UR-NEXT4KH |
| Version Model Number | 1921070150 |
| Company DUNS | 693002487 |
| Company Name | TEAC MANUFACTURING SOLUTIONS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |