| Primary Device ID | 00714646000675 |
| NIH Device Record Key | fb481b45-a8e3-4e65-a1e5-1fdb662384bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ear Wax Removal Kit 12 Ct. Case |
| Version Model Number | 704 |
| Catalog Number | 704 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 12 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | true |
| 00714646001382 - Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement | 2025-06-05 Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement |
| 00714646001399 - Prone Breast, Face Cushion, Replacement | 2025-06-05 Prone Breast, Face Cushion, Replacement |
| 00714646001405 - Prone Breast, Arm Rest, Replacement | 2025-06-05 Prone Breast, Arm Rest, Replacement |
| 00714646001412 - Prone Breast, Leg Cushion, Replacement | 2025-06-05 Prone Breast, Leg Cushion, Replacement |
| 00714646001429 - Prone Breast, Hand Post Assembly, Replacement | 2025-06-05 Prone Breast, Hand Post Assembly, Replacement |
| 00714646001436 - Prone Breast, Hardware Kit, Threaded Indexing Pegs | 2025-06-05 Prone Breast, Hardware Kit, Threaded Indexing Pegs |
| 00714646001443 - Prone Breast, Hardware Kit, Head Rest Push Button Assembly Replacement | 2025-06-05 Prone Breast, Hardware Kit, Head Rest Push Button Assembly, Replacement |
| 00714646001450 - Prone Breast, Hardware Kit, Head Rest Carriage, Replacement | 2025-06-05 Prone Breast, Hardware Kit, Head Rest Carriage, Replacement |