Novo Surgical Inc.
house incudostapedial joint knife, circular tip, octagonal handle, 0.75 mm diameter blade, angled 60 degrees, 6 1/2" (16.5 cm)
2manufacturers in China registered for this device type
38catalogue 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 | KTG |
| Device type | Knife, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-10 |
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 |
|---|---|---|
| E7214-80 | In distribution | |
| E7761-25 | In distribution | |
| E7761-14 | In distribution | |
| E7761-26 | In distribution | |
| E7213-79 | In distribution | |
| E7761-15 | In distribution | |
| E7214-89 | In distribution | |
| E7821-53 | In distribution | |
| E7315-93 | In distribution | |
| E7215-82 | In distribution | |
| E7214-92 | In distribution | |
| E7821-54 | In distribution | |
| E7486-91 | In distribution | |
| E7851-57 | In distribution | |
| E7421-52 | In distribution | |
| E7761-16 | In distribution | |
| E7214-26 | In distribution | |
| E7248-90 | In distribution | |
| E7214-93 | In distribution | |
| E7315-92 | In distribution | |
| E7214-88 | In distribution | |
| E7315-91 | In distribution | |
| E7821-91 | In distribution | |
| E7821-46 | In distribution | |
| E7821-31 | In distribution | |
| E7763-21 | In distribution | |
| E7821-51 | In distribution | |
| E7214-07 | In distribution | |
| E7215-81 | In distribution | |
| E7486-93 | In distribution | |
| E7214-08 | In distribution | |
| E7821-71 | In distribution | |
| E7213-84 | In distribution | |
| E7761-24 | In distribution | |
| E7214-06 | In distribution | |
| E7821-41 | In distribution | |
| E7763-71 | In distribution | |
| E8556-21 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Boss Instruments | Boss Instruments, Ltd. | 91 |
| Ambler Surgical | Ambler Surgical, LLC | 87 |
| Aesculap | Aesculap AG | 48 |
| Pilling | Teleflex Medical LLC | 47 |
| Millennium | Avalign Technologies, Inc. | 41 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 31 |
| Avalign | Avalign Technologies, Inc. | 30 |
| HNM Medical | HNM Stainless, LLC. | 27 |
| V. Mueller | Steris Corporation | 25 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 25 |
| Rosen round knife | Spiggle & Theis Medizintechnik Gmbh | 22 |
| BR Surgical, LLC | BR Surgical LLC | 21 |
Showing 12 of 83. All products under Knife, Ent
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.