| Primary Device ID | 06970663420047 |
| NIH Device Record Key | 18e31876-f86a-4f5e-b45f-ab6244b12df4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UTK |
| Version Model Number | H-14B1N |
| Company DUNS | 544434373 |
| Company Name | UTK TECHNOLOGY(SHENZHEN)LIMITED |
| 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 | false |
| 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 | true |