Gyrus Acmi
Blu Ear Packing, with drawstring,12 mm x 15 mm, Bacteriostatic
2manufacturers in China registered for this device type
4catalogue 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 | Gyrus Acmi, Inc., 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 | 2018-09-11 |
| Record revised | 2025-01-09 (version 4) |
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, expiry date |
| Packaging | Pack of 10, pack of 50 |
| Distribution end date | 2026-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 140320 | In distribution | |
| 7089-0858 | Withdrawn | |
| 7089-0859 | Withdrawn | |
| 7089-0860 | Withdrawn |
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 |
| Ear Wick | Summit Medical LLC | 7 |
| Collin | Network Medical Products, Ltd. | 6 |
| Otocell® Ear Wick | Boston Medical Products, 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.