| Primary Device ID | 00817020020846 |
| NIH Device Record Key | 2b9a5e5c-0561-4b96-bc4b-38d06ee9d4f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartScreener-Plus2 OAE Module |
| Version Model Number | M813010 |
| Company DUNS | 154870455 |
| Company Name | INTELLIGENT HEARING SYSTEMS CORP. |
| 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 | false |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817020020846 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-12 |
| Device Publish Date | 2016-09-24 |
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| 00817020021058 - Bone Vibrator w/ Cable and Headband (B81) | 2021-02-18 |
| 00817020021065 - DD45-300 Headphones | 2021-02-18 |
| 00817020020808 - SmartEP Software | 2019-07-12 |
| 00817020020815 - SmartEP-ASSR Software | 2019-07-12 |
| 00817020020822 - SmartScreener-Plus2 Screener Launch | 2019-07-12 |
| 00817020020839 - SmartScreener-Plus2 AEP Module | 2019-07-12 |
| 00817020020846 - SmartScreener-Plus2 OAE Module | 2019-07-12 |
| 00817020020846 - SmartScreener-Plus2 OAE Module | 2019-07-12 |