Orthomed
Chisel Blade 16MM STR. FOR OM49-0630
2manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), 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 |
Record
| Listed by | Ortho-MED, Inc., United States |
|---|---|
| FDA product code | KDG |
| Device type | Chisel (Osteotome) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-10-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OM 49-0045 | In distribution | |
| OM 49-0043 | In distribution | |
| OM 49-0010 | In distribution | |
| OM 49-0264 | In distribution | |
| OM 49-0016 | In distribution | |
| OM 49-0062 | In distribution | |
| OM 49-0040 | In distribution | |
| OM 49-0250 | In distribution | |
| OM 49-0080 | In distribution | |
| OM 49-0012 | In distribution | |
| OM 46-0505 | In distribution | |
| OM 49-0066 | In distribution | |
| OM 49-0075 | In distribution | |
| OM 49-0652 | In distribution | |
| OM 49-0014 | In distribution | |
| OM 49-0063 | In distribution | |
| OM 49-0074 | In distribution | |
| OM 49-0081 | In distribution | |
| OM 49-0246 | In distribution | |
| OM 49-0660 | In distribution | |
| OM 49-0059 | In distribution | |
| OM 49-0268 | In distribution | |
| OM 69-0640 | In distribution | |
| OM 46-0291 | In distribution | |
| OM 49-0065 | In distribution | |
| OM 69-0645 | In distribution | |
| OM 46-0507 | In distribution | |
| OM 49-0073 | In distribution | |
| OM 49-0266 | In distribution | |
| OM 49-0258 | In distribution | |
| OM 46-0509 | In distribution | |
| OM 49-0078 | In distribution | |
| OM 49-0060 | In distribution | |
| OM 49-0248 | In distribution | |
| OM 49-0252 | In distribution | |
| OM 46-0506 | In distribution | |
| OM 49-0664 | In distribution | |
| OM 49-0260 | In distribution | |
| OM 49-0656 | In distribution | |
| OM 49-0041 | In distribution | |
| OM 46-0290 | In distribution | |
| OM 46-0508 | In distribution | |
| OM 49-0042 | In distribution | |
| OM 49-0256 | In distribution | |
| OM 49-0061 | In distribution | |
| OM 49-0076 | In distribution | |
| OM 49-0068 | In distribution | |
| OM 49-0064 | In distribution | |
| OM 49-0079 | In distribution | |
| OM 49-0067 | In distribution | |
| OM 49-0044 | In distribution | |
| OM 49-0262 | In distribution | |
| OM 49-0254 | In distribution | |
| OM 69-0630 | In distribution | |
| OM 49-0082 | In distribution | |
| OM 69-0650 | In distribution | |
| OM 46-0289 | In distribution | |
| OM 49-0077 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 531 |
| Quinelato | Schobell Industrial Ltda | 70 |
| Novo Surgical | Novo Surgical, Inc. | 67 |
| Stille Osteotomes | Stille AB | 65 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 65 |
| Life Instruments | Life Instrument Corp. | 57 |
| Princeton | Princeton Medical Group, Inc. | 46 |
| Osteotome | Koros U.S.A., Inc. | 41 |
| Elmed | Elmed, Inc. | 41 |
| Anmuth Medical International | Anmuth Medical International LLC | 32 |
| Aesculap | Aesculap AG | 31 |
| Chisel | Koros U.S.A., Inc. | 27 |
Showing 12 of 55. All products under Chisel (Osteotome)
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.