Elmed Incorporated
Neivert osteotome. Guarded. Straight. Cutting edge 5mm. Overall length 8in (20.3cm).
2manufacturers in China registered for this device type
18catalogue 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 | Elmed, Inc., United States |
|---|---|
| FDA product code | KDG |
| Device type | Chisel (Osteotome) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-17 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST3365007 | In distribution | |
| 23-242101 | In distribution | |
| 23-242103 | In distribution | |
| 23-0819C | In distribution | |
| ST4747403 | In distribution | |
| 23-7501010-0 | In distribution | |
| 23-7501025-0 | In distribution | |
| 23-7501012-0 | In distribution | |
| 24-10739 | In distribution | |
| 23-242109000 | In distribution | |
| 23-242101000 | In distribution | |
| 23-242106 | In distribution | |
| ST4747145M | In distribution | |
| ST3367216 | In distribution | |
| ST4746314 | In distribution | |
| 23-242104 | In distribution | |
| STSM230913JC | In distribution | |
| 23-242105 | 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 |
| Orthomed | Ortho-MED, Inc. | 58 |
| 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 |
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.