Novo Surgical
lexer chisel, w/ sterilizable (up to 143 degrees c) plastic handle, 25.0 mm, 8 5/8" (22.0 cm)
2manufacturers in China registered for this device type
67catalogue 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 | Novo Surgical, 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 | 2023-12-18 |
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 |
|---|---|---|
| N3937-23 | In distribution | |
| N3961-73 | In distribution | |
| N93961-73 | In distribution | |
| N3937-21 | In distribution | |
| N93961-23 | In distribution | |
| N93961-91 | In distribution | |
| N93961-36 | In distribution | |
| N3931-29 | In distribution | |
| N3965-18 | In distribution | |
| N3965-43 | In distribution | |
| N3965-49 | In distribution | |
| N93961-33 | In distribution | |
| N3961-93 | In distribution | |
| N3961-77 | In distribution | |
| N93961-81 | In distribution | |
| N93961-93 | In distribution | |
| N3965-40 | In distribution | |
| N93931-23 | In distribution | |
| N3965-47 | In distribution | |
| N93937-15 | In distribution | |
| N3965-21 | In distribution | |
| D5451-22 | In distribution | |
| N3961-41 | In distribution | |
| N93961-41 | In distribution | |
| N3961-99 | In distribution | |
| N93961-21 | In distribution | |
| N93937-17 | In distribution | |
| N3965-16 | In distribution | |
| N3954-36 | In distribution | |
| N93961-51 | In distribution | |
| N3965-44 | In distribution | |
| N3937-15 | In distribution | |
| N3937-19 | In distribution | |
| N3937-17 | In distribution | |
| N93961-99 | In distribution | |
| N93961-67 | In distribution | |
| D5451-26 | In distribution | |
| N93961-17 | In distribution | |
| N93954-21 | In distribution | |
| N93937-19 | In distribution | |
| N3965-26 | In distribution | |
| N93954-31 | In distribution | |
| N93961-71 | In distribution | |
| N93937-25 | In distribution | |
| N93954-26 | In distribution | |
| N93931-29 | In distribution | |
| N3961-91 | In distribution | |
| N3965-42 | In distribution | |
| N93931-17 | In distribution | |
| N93937-23 | In distribution | |
| N3961-81 | In distribution | |
| D5451-18 | In distribution | |
| N3961-83 | In distribution | |
| N3961-71 | In distribution | |
| N93961-27 | In distribution | |
| N93961-86 | In distribution | |
| N3965-23 | In distribution | |
| N3937-25 | In distribution | |
| N93961-83 | In distribution | |
| N3961-51 | In distribution | |
| N93954-36 | In distribution | |
| N93961-77 | In distribution | |
| N3965-46 | In distribution | |
| N93961-31 | In distribution | |
| N93937-21 | In distribution | |
| N3931-23 | In distribution | |
| N93961-43 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 531 |
| Quinelato | Schobell Industrial Ltda | 70 |
| 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 |
| 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.