| Primary Device ID | 00786511786809 |
| NIH Device Record Key | 5250e23c-85c9-4f8a-9b18-b5d34c8a9b25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Otoscope |
| Version Model Number | 3430-BLK |
| Company DUNS | 078803608 |
| Company Name | RASHMAN 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 | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00786511786809 [Primary] |
| LDE | Stethoscope, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-14 |
| Device Publish Date | 2022-12-06 |
| 00786511834203 | Standard Pocket Otoscope |
| 00786511786809 | Mini OtoLite Otoscope |
| 00786511392444 | Xenon Pocket Otoscope |
| 00786511034207 | Standard Pocket Otoscope |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OTOSCOPE 77875618 3905524 Live/Registered |
Smith, Richard J.H. 2009-11-18 |