| Primary Device ID | 00627908020123 |
| NIH Device Record Key | e2f7dd3b-e540-423d-9745-db55715846d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integrity OAE Probe |
| Version Model Number | P81-UG |
| Company DUNS | 201740425 |
| Company Name | Vivosonic Inc |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627908020123 [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 | 2020-04-21 |
| Device Publish Date | 2016-09-23 |
| 00062790820121 | UG OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00062 |
| 00062790820114 | GP OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00062 |
| 00062790810078 | UG OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00062 |
| 00062790810061 | GP OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00062 |
| 00627908020123 | UG OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00627 |
| 00627908020116 | GP OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00627 |
| 00627908010070 | UG OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627 |
| 00627908010063 | GP OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627 |