ACE
BUR Circular SAW 22MM 5HD.6MM Thick Contra Angle
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Ace Surgical Supply Co., Inc., United States |
|---|---|
| FDA product code | HAB |
| Device type | Saw, Powered, And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Premarket notification | Exempt |
| Record published | 2019-10-12 |
| Record revised | 2020-06-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Storage | Special storage condition: No special storage conditions required |
| Sizes | Outer diameter 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00230080 | Outer Diameter 5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Saw, Powered, And Accessories | Smith & Nephew, Inc. | 179 |
| Dyonics | Smith & Nephew, Inc. | 49 |
| Zimmer Biomet™ | Zimmer Surgical, Inc. | 43 |
| PowerPro | ConMed Corporation | 29 |
| Saw, Powered, And Accessories | Zimmer Surgical, Inc. | 27 |
| FJ2000 System | Paragon 28 | 26 |
| Dyonics Power | Smith & Nephew, Inc. | 19 |
| Traus | Saeshin Precision Co., Ltd. | 19 |
| Aesculap | Aesculap AG | 17 |
| Hall Microfree | ConMed Corporation | 11 |
| Dyonics / Incisor | Smith & Nephew, Inc. | 7 |
| Apex 3D Total Ankle Replacement System | Paragon 28 | 7 |
Showing 12 of 84. All products under Saw, Powered, And Accessories
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.