Yoshida Diamond Coated Burr
Catalogue number AE-3254, listed by Katena Products, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
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 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | OHW |
| Device type | Burr, Corneal, Battery Powered, Rust Ring Removal |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AE-3254 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 25 |
| Burr | Katena Products, Inc. | 10 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 6 |
| Algerbrush Diamond Burr | Sontec Instruments, Inc. | 5 |
| Algerbrush II | THE Alger Company, Inc. | 2 |
| Algerbrush Burr | Sontec Instruments, Inc. | 2 |
| Algerbrush II Corneal Rust Ring Remover | Sontec Instruments, Inc. | 2 |
| Algerbrush Corn Rust Ring REM 0.5MM Burr | Katena Products, Inc. | 1 |
| Algerbrush Rust Ring REM CHUCK.5MM Burr | Katena Products, Inc. | 1 |
| Algerbrush II Pterygium 3.5 RND MED Diam | Katena Products, Inc. | 1 |
| Algerbrush Rust Ring REM Burr 0.5MM | Katena Products, Inc. | 1 |
| Algerbrush Corn Rust Ring REM Burr 1.0MM | Katena Products, Inc. | 1 |
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.