| Primary Device ID | 00643169645004 |
| NIH Device Record Key | 5b8369c5-baf4-4675-96c7-36b2e040c125 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Otomag™ Binaural Softband |
| Version Model Number | S0264-22 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 00643169645004 [Primary] |
| LXB | Hearing aid, bone conduction |
| 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 | 2016-04-17 |
| 00643169645042 | SOFTBAND S0264-42 PALE PINK BINAURAL |
| 00643169645028 | SOFTBAND S0264-32 CAFE BINAURAL |
| 00643169645004 | SOFTBAND S0264-22 WHITE BINAURAL |
| 00643169644984 | SOFTBAND S0264-12 BLACK BINAURAL |