| Primary Device ID | 00643169645011 |
| NIH Device Record Key | 253a133b-55b1-4e98-b648-2e7efad26882 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Otomag™ Monaural Softband |
| Version Model Number | S0264-31 |
| 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 | 00643169645011 [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 |
| 00643169645035 | SOFTBAND S0264-41 PALE PINK MONAURAL |
| 00643169645011 | SOFTBAND S0264-31 CAFE MONAURAL |
| 00643169644991 | SOFTBAND S0264-21 WHITE MONAURAL |
| 00643169644977 | SOFTBAND S0264-11 BLACK MONAURAL |