PowerPro
PowerPro Small 12 Volt Sterile Transfer Battery Case
2manufacturers in China registered for this device type
29catalogue numbers in this listing
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 | ConMed Corporation, United States |
|---|---|
| FDA product code | HAB |
| Device type | Saw, Powered, And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K012320 |
| Record published | 2020-09-24 |
| Record revised | 2024-03-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: KEEP DRY |
| Packaging | Pouch of 50 |
| Sizes | Outer diameter 0.125 to 0.25 in; outer diameter 4 to 6.5 mm |
| Distribution end date | 2023-11-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PRO2060 | In distribution | ||
| PRO2043 | In distribution | ||
| PRO2514 | In distribution | ||
| PRO2065 | In distribution | ||
| PRO3531 | In distribution | ||
| PRO3130 | In distribution | ||
| PRO2045 | In distribution | ||
| PRO3110 | In distribution | ||
| PRO3600 | In distribution | ||
| PRO3135 | In distribution | ||
| PRO2046 | In distribution | ||
| PRO6040 | In distribution | ||
| PRO2030 | Outer Diameter 4 mm | In distribution | |
| PRO3521 | In distribution | ||
| PRO2250 | Outer Diameter 0.25 in | In distribution | |
| PRO2029 | In distribution | ||
| PRO6048 | In distribution | ||
| PRO2042 | Outer Diameter 6.5 mm | In distribution | |
| PRO3535 | In distribution | ||
| PRO2041 | Outer Diameter 0.25 in | In distribution | |
| PRO6047 | In distribution | ||
| PRO6050 | Outer Diameter 0.125 in | In distribution | |
| PRO2040 | In distribution | ||
| PRO2047 | In distribution | ||
| PRO7020 | In distribution | ||
| PRO2041RFB | Outer Diameter 6.5 mm | Withdrawn | |
| PRO3205 | 50 | Withdrawn | |
| PRO2030RFB | Outer Diameter 0.15625 in | Withdrawn | |
| PRO3600 | Withdrawn |
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 |
| 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 |
| Hall® Titan™ | ConMed Corporation | 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.