Osseous
Ear PVA Dressings sponges are designed to be placed inside ear canal for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and aid the…
Ear PVA Dressings sponges are designed to be placed inside ear canal for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and aid the treatment of otitis external.
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 | EON Meditech PVT. Ltd., India |
|---|---|
| FDA product code | KCN |
| Device type | Ear Wick |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-06-11 |
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, manufacturing date |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Laminated box of 10, laminated box of 20 |
| Sizes | Outer diameter 9 to 12 mm; length 15 to 24 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E7161 | Outer Diameter 9 mm | In distribution |
| E7167-OC | Outer Diameter 12 mm | In distribution |
| E7162-OC | Outer Diameter 9 mm | In distribution |
| E7170 | Outer Diameter 09 mm | In distribution |
| E7169-OC | Outer Diameter 09 mm | In distribution |
| E7169 | Outer Diameter 09 mm | In distribution |
| E7163 | Outer Diameter 12 mm | In distribution |
| E7162-O | Outer Diameter 9 mm | In distribution |
| E7168 | Outer Diameter 12 mm | In distribution |
| E7165-OC | Outer Diameter 09 mm | In distribution |
| E7164-O | Outer Diameter 12 mm | In distribution |
| E7168-O | Outer Diameter 12 mm | In distribution |
| E7165 | Outer Diameter 09 mm | In distribution |
| E7168-OC | Outer Diameter 12 mm | In distribution |
| E7163-OC | Outer Diameter 12 mm | In distribution |
| E7162 | Outer Diameter 9 mm | In distribution |
| E7169-O | Outer Diameter 09 mm | In distribution |
| E7161-OC | Outer Diameter 09 mm | In distribution |
| E7170-OC | Outer Diameter 09 mm | In distribution |
| E7165-O | Outer Diameter 09 mm | In distribution |
| E7170-O | Outer Diameter 09 mm | In distribution |
| E7166 | Outer Diameter 09 mm | In distribution |
| E7166-OC | Outer Diameter 09 mm | In distribution |
| E7167 | Outer Diameter 12 mm | In distribution |
| E7164-OC | Outer Diameter 12 mm | In distribution |
| E7163-O | Outer Diameter 12 mm | In distribution |
| E7164 | Outer Diameter 12 mm | In distribution |
| E7167-O | Outer Diameter 12 mm | In distribution |
| E7161-O | Outer Diameter 09 mm | In distribution |
| E7166-O | Outer Diameter 09 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merocel® | Medtronic Xomed, Inc. | 16 |
| Netcell | Network Medical Products, Ltd. | 15 |
| Fabco | First AID Bandage Co Inc | 8 |
| Ear Wick | Summit Medical LLC | 7 |
| 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.