Novo Surgical Inc.
zenith mallet, lightweight, 7 1/2" (19.1 cm), 9.0 oz., 1 side of head stainless steel, other side replaceable nylon cap, 1" head diam.
3manufacturers in China registered for this device type
30catalogue numbers in this listing
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 Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | GFJ |
| Device type | Mallet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N3817-41 | In distribution | |
| N93817-41 | In distribution | |
| E7413-16 | In distribution | |
| E7413-17 | In distribution | |
| N93819-51 | In distribution | |
| N93813-24 | In distribution | |
| N93815-12 | In distribution | |
| N3815-33 | In distribution | |
| E97413-17 | In distribution | |
| N3819-77 | In distribution | |
| N3815-11 | In distribution | |
| N3819-00 | In distribution | |
| N3819-81 | In distribution | |
| E7851-31 | In distribution | |
| E7851-61 | In distribution | |
| E97413-11 | In distribution | |
| N3819-51 | In distribution | |
| N93815-31 | In distribution | |
| E7413-11 | In distribution | |
| N3815-31 | In distribution | |
| E97413-16 | In distribution | |
| N3815-12 | In distribution | |
| NS399.42 | In distribution | |
| N93819-00 | In distribution | |
| N3819-68 | In distribution | |
| N93815-11 | In distribution | |
| E7413-18 | In distribution | |
| N3819-91 | In distribution | |
| N3813-24 | In distribution | |
| N3817-42 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 86 |
| Millennium | Avalign Technologies, Inc. | 67 |
| gSource | Gsource, LLC. | 62 |
| Boss Instruments | Boss Instruments, Ltd. | 43 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| Surtex | Surtex Instruments Ltd | 36 |
| Orthomed | Ortho-MED, Inc. | 28 |
| HNM Medical | HNM Stainless, LLC. | 26 |
| Kmedic | Teleflex Medical LLC | 23 |
| Avalign | Avalign Technologies, Inc. | 23 |
| V. Mueller | Steris Corporation | 22 |
| Mallet | KLS-Martin L.P. | 19 |
Showing 12 of 91. All products under Mallet, Surgical, General & Plastic Surgery
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.