| Primary Device ID | 00817020020716 |
| NIH Device Record Key | bff48f84-566a-4eda-88dc-5d4363ad497e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Screener Cart |
| Version Model Number | M998920 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817020020716 [Primary] |
| GWJ | Stimulator, Auditory, Evoked Response |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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