Merocel®
Packing 400354 Merocel 20PK Ambrus EAR
2manufacturers in China registered for this device type
16catalogue 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 | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | KCN |
| Device type | Ear Wick |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-09-09 |
| Record revised | 2021-03-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Pack of 100 |
| Sizes | Outer diameter 3 to 15 mm; length 13 to 24 mm; width 9 to 15 mm |
| Distribution end date | 2023-12-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 400144 | Outer Diameter 12.0 mm | 10 | In distribution |
| 400162 | Length 24.0 mm | 10 | In distribution |
| 400354 | Length 20.0 mm | 20 | In distribution |
| 400146 | Outer Diameter 9.0 mm | 10 | In distribution |
| 400354 | Length 20.0 mm | 20 | In distribution |
| 400152 | Outer Diameter 5.0 mm | 100 | In distribution |
| 400150 | Outer Diameter 3.0 mm | 100 | In distribution |
| 425141 | Width 9.0 mm | 25 | In distribution |
| 400355 | Outer Diameter 12.0 mm | 10 | In distribution |
| 400152 | Outer Diameter 5.0 mm | In distribution | |
| 400357 | Length 13.0 mm | 10 | In distribution |
| 400151 | Outer Diameter 4.0 mm | In distribution | |
| 400141 | Length 15.0 mm | 50 | In distribution |
| 400356 | Outer Diameter 9.0 mm | 10 | In distribution |
| 400151 | Outer Diameter 4.0 mm | 100 | In distribution |
| 400162 | Width 12.0 mm | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseous | EON Meditech PVT. Ltd. | 30 |
| 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.