Sklar®
Censitrac Ready Bruns Curette Oval Size 4-0 STR 9 Inches
4manufacturers in China registered for this device type
537catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | FZS |
| Device type | Curette, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-29 |
| Record revised | 2019-05-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 40-7224C | In distribution | ||
| 41-1825 | In distribution | ||
| 06-4115C | In distribution | ||
| 40-7173 | In distribution | ||
| 41-1934 | In distribution | ||
| 06-4002 | In distribution | ||
| 41-1974 | In distribution | ||
| 40-7243 | In distribution | ||
| 41-1905 | In distribution | ||
| 41-1859 | In distribution | ||
| 97-0532 | In distribution | ||
| 41-1893 | In distribution | ||
| 40-7383 | In distribution | ||
| 06-4137 | In distribution | ||
| 41-1991 | In distribution | ||
| 06-4141 | In distribution | ||
| 06-4112 | In distribution | ||
| 41-1868 | In distribution | ||
| 40-7247 | In distribution | ||
| 41-1700 | In distribution | ||
| 41-1992 | In distribution | ||
| 98-7306 | In distribution | ||
| 40-7396 | In distribution | ||
| 41-1908 | In distribution | ||
| 41-1945 | In distribution | ||
| 97-0564 | In distribution | ||
| 40-7114 | In distribution | ||
| 40-1736 | In distribution | ||
| 06-4133C | In distribution | ||
| 41-1949 | In distribution | ||
| 21-186 | 12 | In distribution | |
| 41-1931 | In distribution | ||
| 41-1737 | In distribution | ||
| 97-0524 | In distribution | ||
| 06-4130 | In distribution | ||
| 40-7201 | In distribution | ||
| 41-1955 | In distribution | ||
| 41-1987 | In distribution | ||
| 40-7226C | In distribution | ||
| 79-3103 | In distribution | ||
| 40-7242C | In distribution | ||
| 40-7182 | In distribution | ||
| 45-6034 | In distribution | ||
| 41-1942 | In distribution | ||
| 98-186 | In distribution | ||
| 41-1971 | In distribution | ||
| 41-1975 | In distribution | ||
| 97-0532C | In distribution | ||
| 79-3141 | In distribution | ||
| 41-1826 | In distribution | ||
| 41-1744 | In distribution | ||
| 40-7208 | In distribution | ||
| 41-1732 | In distribution | ||
| 41-1951 | In distribution | ||
| 40-7248 | In distribution | ||
| 41-1718C | In distribution | ||
| 41-1736 | In distribution | ||
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| 06-4129 | In distribution | ||
| 70-9302 | In distribution | ||
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| 06-4136 | In distribution | ||
| 40-7202C | In distribution | ||
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| 41-1925 | In distribution | ||
| 70-9213 | In distribution | ||
| 79-3146 | In distribution | ||
| 06-4133 | In distribution | ||
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| 41-1989 | In distribution | ||
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| 40-7115 | In distribution | ||
| 21-171 | 12 | In distribution | |
| 41-1872 | In distribution | ||
| 06-4135 | In distribution | ||
| 40-7357 | In distribution | ||
| 40-7129C | In distribution | ||
| 41-1870 | In distribution | ||
| 40-7100C | In distribution | ||
| 40-8132 | In distribution | ||
| 40-7222C | In distribution | ||
| 41-1804 | In distribution | ||
| 40-7204C | In distribution | ||
| 41-1815 | In distribution | ||
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| 41-1920 | In distribution | ||
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| 06-4113C | In distribution | ||
| 41-1924C | In distribution | ||
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| 79-3121 | In distribution | ||
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| 41-1950 | In distribution | ||
| 98-7302 | In distribution | ||
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| 40-7114C | In distribution | ||
| 06-4130C | In distribution | ||
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| 41-1904 | In distribution | ||
| 06-4141C | In distribution | ||
| 40-7246 | In distribution | ||
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| 40-8114 | In distribution | ||
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| 06-4006 | In distribution | ||
| 41-1807 | In distribution | ||
| 79-3147 | In distribution | ||
| 41-1915 | In distribution | ||
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| 06-4131 | In distribution | ||
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| 41-1965 | In distribution | ||
| 40-7334 | In distribution | ||
| 06-4127 | In distribution | ||
| 41-1947 | In distribution | ||
| 41-1851 | In distribution | ||
| 97-0536C | In distribution | ||
| 41-1943 | In distribution | ||
| 45-6013 | In distribution | ||
| 41-1914 | In distribution | ||
| 06-4115 | In distribution | ||
| 40-7228C | In distribution | ||
| 21-172 | 12 | In distribution | |
| 40-7220 | In distribution | ||
| 40-7387 | In distribution | ||
| 98-503 | In distribution | ||
| 41-1720 | In distribution | ||
| 40-7210 | In distribution | ||
| 40-7203 | In distribution | ||
| 40-7120 | In distribution | ||
| 79-3122 | In distribution | ||
| 41-1716 | In distribution | ||
| 41-1864 | In distribution | ||
| 41-1926 | In distribution | ||
| 41-1701 | In distribution | ||
| 41-1993 | In distribution | ||
| 06-4135C | In distribution | ||
| 40-7100 | In distribution | ||
| 40-7144 | In distribution | ||
| 41-1841 | In distribution | ||
| 98-413 | In distribution | ||
| 40-7330 | In distribution | ||
| 40-7388 | In distribution | ||
| 41-1819 | In distribution | ||
| 41-1865 | In distribution | ||
| 40-7386 | In distribution | ||
| 06-4003 | In distribution | ||
| 41-1820 | In distribution | ||
| 40-7165 | In distribution | ||
| 40-7145 | In distribution | ||
| 41-1842 | In distribution | ||
| 40-7358 | In distribution | ||
| 40-7286 | In distribution | ||
| 41-1816 | In distribution | ||
| 06-4140C | In distribution | ||
| 41-1832 | In distribution | ||
| 06-4140 | In distribution | ||
| 41-1703 | In distribution | ||
| 06-4134C | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Instruments | Life Instrument Corp. | 1,651 |
| gSource | Gsource, LLC. | 498 |
| Aesculap | Aesculap AG | 477 |
| Surtex | Surtex Instruments Ltd | 462 |
| HNM Medical | HNM Stainless, LLC. | 412 |
| Curette | Koros U.S.A., Inc. | 341 |
| Boss Instruments | Boss Instruments, Ltd. | 311 |
| Gen2 | Surgix Medical LLC | 301 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 295 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 248 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 192 |
| SurgiPros | Surgipros LLC | 184 |
Showing 12 of 245. All products under Curette, Surgical, General Use
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 0 units |
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.