Ear Wick
7 catalogue numbers from OT-5203-10, listed by Summit Medical LLC, United States, under Ear Wick. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Summit Medical LLC, United States |
|---|---|
| FDA product code | KCN |
| Device type | Ear Wick |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-12 |
| Record revised | 2021-08-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 50, shelf box of 10, box, box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OT-5203-10 | In distribution | |
| J-1084 | In distribution | |
| OT-5202-50 | In distribution | |
| J-1084A | In distribution | |
| OT-5200-25 | In distribution | |
| OT-5201-50 | In distribution | |
| OT-5204-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseous | EON Meditech PVT. Ltd. | 30 |
| Merocel® | Medtronic Xomed, Inc. | 16 |
| Netcell | Network Medical Products, Ltd. | 15 |
| Fabco | First AID Bandage Co Inc | 8 |
| Collin | Network Medical Products, Ltd. | 6 |
| Otocell® Ear Wick | Boston Medical Products, Inc. | 4 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 4 |
| Ultracell® | Beaver-Visitec International, Ltd | 3 |
| Osseous PVA Corneal Light Shield | EON Meditech PVT. Ltd. | 3 |
| Osseous PVA LASIK Eye Drain | EON Meditech PVT. Ltd. | 2 |
| Osseous PVA Lasik EYE | EON Meditech PVT. Ltd. | 2 |
| Pope Oto-Wick® | Medtronic Xomed, Inc. | 1 |
Showing 12 of 24. All products under Ear Wick
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.