OtoClear SprayWash System, Single Use Sample
Catalogue number 27291, listed by Bionix, LLC, United States, under Applicator, Ent Drug. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
Record
| Listed by | Bionix, LLC, United States |
|---|---|
| FDA product code | LRD |
| Device type | Applicator, Ent Drug |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-11 |
| Record revised | 2025-09-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-09-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 27291 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OtoClear® Ear Irrigation System (220V) | Bionix, LLC | 2 |
| OtoClear® Aquabot® Kit | Bionix, LLC | 2 |
| Bionix Development Corporation | Bionix, LLC | 2 |
| Wush | Guangdong Okay Technology Co., Ltd. | 2 |
| SprayWash Adapter Wand | Bionix, LLC | 1 |
| OtoClear Ear Irrigation System Wands | Bionix, LLC | 1 |
| Exmoor | Exmoor Plastics Limited | 1 |
| Tabletop Waterpik Adapter Wands | Bionix, LLC | 1 |
| Portable WaterPik Adapter Wands | Bionix, LLC | 1 |
| 27275 | Bionix, LLC | 1 |
| 27245 | Bionix, LLC | 1 |
| Ear Wax Removal Kit | Bionix, LLC | 1 |
Showing 12 of 16. All products under Applicator, Ent Drug
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.