Midas Rex Legend
Accy PA115 Legend Tool Storage Rack
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
Record
| Listed by | Medtronic Powered Surgical Solutions, United States |
|---|---|
| FDA product code | HBR |
| Device type | Rack, Clip |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4215 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K020069 |
| Record published | 2021-10-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PA115 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Case Medical, Inc | Case Medical, Inc. | 9 |
| Sugita T2 Clip Tray | Mizuho Corporation | 9 |
| Sugita Titanium Clip II Case | Mizuho Corporation | 5 |
| Sugita Clip Case | Mizuho Corporation | 5 |
| Sugita Titanium Clip Case | Mizuho Corporation | 4 |
| Sugita AVM Microclip II Case | Mizuho Corporation | 3 |
| Sugita Titanium Clips II Case | Mizuho Corporation | 2 |
| Sugita Titanium Clips II Half Case | Mizuho Corporation | 1 |
| Sugita Clip Metal Case | Mizuho Corporation | 1 |
| Sugita Aneurysm Clip Organizational Tray | Mizuho Corporation | 1 |
| Sugita Titanium Clip II Metal Case | Mizuho Corporation | 1 |
| Sugita Titanium Clip II Metal Half Case | Mizuho Corporation | 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.