| Primary Device ID | 00859911004818 |
| NIH Device Record Key | 2eafa4e9-431c-458f-811a-6fb94d4f5b8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OtoClear SprayWash Adapter Wand |
| Version Model Number | 27219 |
| Catalog Number | 27219 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 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 | false |
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| 10714646001105 - Microsuction Replacement Pack | 2025-07-16 Microsuction Replacement Pack |
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| 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 |