| Primary Device ID | 06973919590075 |
| NIH Device Record Key | 21cd9793-775e-486a-87f8-4f0b27b611bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Otoscope |
| Version Model Number | SA39W |
| Company DUNS | 551471161 |
| Company Name | Shenzhen Teslong Technology Co.,Ltd |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06973919590075 [Primary] |
| ERA | Otoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-07 |
| Device Publish Date | 2023-06-29 |
| 06973919590105 | MS500 |
| 06973919590099 | MS450-NTE |
| 06973919590082 | MS430 |
| 06973919590075 | SA39W |
| 06973919590068 | SA39A |
| 06973919590051 | NTE100I |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OTOSCOPE 77875618 3905524 Live/Registered |
Smith, Richard J.H. 2009-11-18 |