Ultracell®
***NON-Sterile*** Shippert MED Fenestrated EAR Wick, 9MM DIA X 15MM (250/SP)
2manufacturers in China registered for this device type
3catalogue 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 | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| 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 |
| 510(k) | K920357 |
| Record published | 2024-06-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SS30315-C | In distribution | |
| SM-NS30305-C | In distribution | |
| SS30301-C | 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 |
| 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 |
| 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
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 3 Boxes | |
| Ultracell Medical Technologies, Inc. | 510(k) number | 2003-01-08 | Not classified | Other | Sterility of the device is compromised | 105.5 boxes | 2012-05-01 |
| Ultracell Medical Technologies, Inc. | 510(k) number | 2003-01-08 | Not classified | Other | Sterility of the device is compromised | 27 boxes | 2012-05-01 |
| Ultracell Medical Technologies, Inc. | 510(k) number | 2003-01-08 | Not classified | Other | Sterility of the device is compromised | 33 boxes | 2012-05-01 |
| Ultracell Medical Technologies, Inc. | 510(k) number | 2003-01-08 | Not classified | Other | Sterility of the device is compromised | 106 boxes | 2012-05-01 |
| Ultracell Medical Technologies, Inc. | 510(k) number | 2003-01-08 | Not classified | Other | Sterility of the device is compromised | 506 units | 2012-05-01 |
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.