Sampedro
Periosteal Elevator, Small Curved Blade, Straight Edge 6MM
3manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Industrias Medicas Sampedro S.A.S, Colombia |
|---|---|
| FDA product code | HWO |
| Device type | Skid, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-18 |
| Record revised | 2024-09-11 (version 2) |
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, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Skid, Bone | Zimmer, Inc. | 2 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 2 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 1 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 1 |
| Novo Surgical | Novo Surgical, Inc. | 1 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 1 |
| Millennium | Avalign Technologies, 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.