| Primary Device ID | 00810153660217 |
| NIH Device Record Key | 20116c5d-0666-45a3-bf12-6717b26cb39c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Go Prime - Black |
| Version Model Number | Go Hearing |
| Catalog Number | GHPA00003BE |
| Company DUNS | 539177681 |
| Company Name | HEARX GROUP (PTY) LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810153660217 [Primary] |
| QUF | Hearing Aid, Air-Conduction, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-27 |
| Device Publish Date | 2024-08-19 |
| 00810153660811 - Lexie Hearing | 2025-08-08 Lexie B2 Powered by Bose (AARP) |
| 00850022464621 - hearX Group | 2025-03-12 The hearOAE (otoacoustic emission device) is a portable, handheld, battery-operated device that can detect hearing loss using Ot |
| 00810153660217 - Go Prime - Black | 2024-08-27Go Prime - Black - Amazon |
| 00810153660217 - Go Prime - Black | 2024-08-27 Go Prime - Black - Amazon |
| 00810153660187 - Go Prime - Beige | 2024-05-27 Go Prime - Beige - In-store |
| 00810153660149 - Lexie Hearing | 2024-03-15 |
| 00810153660156 - Lexie Hearing | 2024-03-15 |
| 00810153660163 - Lexie Hearing | 2024-03-15 |
| 00850022464591 - Go Prime - Beige | 2024-02-20 Go Prime - Beige - In-store |