Sklar®
Censitrac Ready Adson Retr Sharp 4X4 7 1/2 Inches
3manufacturers in China registered for this device type
203catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (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 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | FFO |
| Device type | Retractor, Self-Retaining |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-23 |
| Record revised | 2019-08-21 (version 3) |
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 |
|---|---|---|---|
| 60-6370 | In distribution | ||
| 60-7125 | In distribution | ||
| 42-2092 | In distribution | ||
| 22-8835 | In distribution | ||
| 55-8192 | In distribution | ||
| 55-7340 | In distribution | ||
| 42-1657 | In distribution | ||
| 21-371 | 12 | In distribution | |
| 60-7120 | In distribution | ||
| 42-2102 | In distribution | ||
| 42-1772 | In distribution | ||
| 60-6350 | In distribution | ||
| 22-8760 | In distribution | ||
| 42-1655 | In distribution | ||
| 55-8191 | In distribution | ||
| 60-6580 | In distribution | ||
| 42-1767 | In distribution | ||
| 42-1621 | In distribution | ||
| 60-7200 | In distribution | ||
| 22-8355 | In distribution | ||
| 60-6467 | In distribution | ||
| 47-2840 | In distribution | ||
| 22-8836 | In distribution | ||
| 42-1792 | In distribution | ||
| 42-1995 | In distribution | ||
| 22-8853 | In distribution | ||
| 55-7355 | In distribution | ||
| 42-2095 | In distribution | ||
| 55-8190 | In distribution | ||
| 60-7125C | In distribution | ||
| 42-1750 | In distribution | ||
| 22-8255 | In distribution | ||
| 42-1875 | In distribution | ||
| 60-6240 | In distribution | ||
| 97-388 | In distribution | ||
| 22-8842 | In distribution | ||
| 22-8855 | In distribution | ||
| 60-7110 | In distribution | ||
| 60-6352 | In distribution | ||
| 42-2110 | In distribution | ||
| 95-805 | In distribution | ||
| 42-1665 | In distribution | ||
| 47-2914 | In distribution | ||
| 42-2111 | In distribution | ||
| 97-371 | In distribution | ||
| 42-2085 | In distribution | ||
| 42-2078 | In distribution | ||
| 47-2831 | In distribution | ||
| 42-1790 | In distribution | ||
| 42-1641 | In distribution | ||
| 42-1620 | In distribution | ||
| 42-1656 | In distribution | ||
| 42-1865 | In distribution | ||
| 55-8199 | In distribution | ||
| 42-1425 | In distribution | ||
| 22-8850 | In distribution | ||
| 42-1751 | In distribution | ||
| 55-8195 | In distribution | ||
| 47-2834 | In distribution | ||
| 22-8245 | In distribution | ||
| 22-8832 | In distribution | ||
| 42-1866 | In distribution | ||
| 42-1421 | In distribution | ||
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| 55-8194 | In distribution | ||
| 42-1670 | In distribution | ||
| 60-6870 | In distribution | ||
| 42-1765 | In distribution | ||
| 60-6313 | In distribution | ||
| 47-2912 | In distribution | ||
| 55-7342 | In distribution | ||
| 90-1885 | In distribution | ||
| 60-6320 | In distribution | ||
| 60-6595 | In distribution | ||
| 60-6342 | In distribution | ||
| 22-8920C | In distribution | ||
| 60-7113 | In distribution | ||
| 55-7345 | In distribution | ||
| 22-8839 | In distribution | ||
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| 42-1645 | In distribution | ||
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| 42-1510 | In distribution | ||
| 42-2076 | In distribution | ||
| 22-8920 | In distribution | ||
| 42-1995C | In distribution | ||
| 98-805 | In distribution | ||
| 55-7341 | In distribution | ||
| 55-7990 | In distribution | ||
| 42-1611 | In distribution | ||
| 60-7115 | In distribution | ||
| 55-8197 | In distribution | ||
| 55-7344 | In distribution | ||
| 60-7120C | In distribution | ||
| 42-1610 | In distribution | ||
| 57-1325 | In distribution | ||
| 42-1775C | In distribution | ||
| 22-8355C | In distribution | ||
| 22-8846 | In distribution | ||
| 60-7130 | In distribution | ||
| 42-1820 | In distribution | ||
| 55-7575 | In distribution | ||
| 42-2103 | In distribution | ||
| 22-8838 | In distribution | ||
| 42-1561 | In distribution | ||
| 22-8845 | In distribution | ||
| 42-1785 | In distribution | ||
| 60-6315 | In distribution | ||
| 42-1965 | In distribution | ||
| 97-376 | In distribution | ||
| 42-1965C | In distribution | ||
| 42-1810 | In distribution | ||
| 42-1511 | In distribution | ||
| 22-8230 | In distribution | ||
| 47-2845 | In distribution | ||
| 42-2100 | In distribution | ||
| 60-6348 | In distribution | ||
| 22-8833 | In distribution | ||
| 22-8940C | In distribution | ||
| 42-1830 | In distribution | ||
| 22-8853C | In distribution | ||
| 60-6670 | In distribution | ||
| 42-2075 | In distribution | ||
| 42-1662 | In distribution | ||
| 60-6340C | In distribution | ||
| 55-8200 | In distribution | ||
| 42-1811 | In distribution | ||
| 42-1770 | In distribution | ||
| 47-2838 | In distribution | ||
| 60-6570 | In distribution | ||
| 47-1320 | In distribution | ||
| 57-1322 | In distribution | ||
| 47-2830 | In distribution | ||
| 42-1642 | In distribution | ||
| 60-7140 | In distribution | ||
| 42-1646 | In distribution | ||
| 42-1975C | In distribution | ||
| 60-6590 | In distribution | ||
| 97-384 | In distribution | ||
| 55-7650 | In distribution | ||
| 22-8245C | In distribution | ||
| 22-8345C | In distribution | ||
| 42-1420 | In distribution | ||
| 42-1635 | In distribution | ||
| 42-2101 | In distribution | ||
| 42-1864 | In distribution | ||
| 47-2910 | In distribution | ||
| 22-8940 | In distribution | ||
| 97-372 | In distribution | ||
| 97-373 | In distribution | ||
| 60-6710 | In distribution | ||
| 55-8193 | In distribution | ||
| 42-1640 | In distribution | ||
| 97-370 | In distribution | ||
| 42-1560 | In distribution | ||
| 22-7825 | In distribution | ||
| 42-1661 | In distribution | ||
| 60-7110C | In distribution | ||
| 42-1865C | In distribution | ||
| 95-371 | In distribution | ||
| 42-1832 | In distribution | ||
| 42-1775 | In distribution | ||
| 42-1663 | In distribution | ||
| 42-1764 | In distribution | ||
| 22-8855C | In distribution | ||
| 42-1664 | In distribution | ||
| 42-1795 | In distribution | ||
| 42-1660 | In distribution | ||
| 60-7135 | In distribution | ||
| 22-8851 | In distribution | ||
| 42-1643 | In distribution | ||
| 60-6570C | In distribution | ||
| 22-9030 | In distribution | ||
| 42-1856 | In distribution | ||
| 47-2832 | In distribution | ||
| 42-1855 | In distribution | ||
| 47-2913 | In distribution | ||
| 42-1830C | In distribution | ||
| 97-378 | In distribution | ||
| 42-1671 | In distribution | ||
| 60-6310 | In distribution | ||
| 42-1766 | In distribution | ||
| 22-8345 | In distribution | ||
| 60-7112 | In distribution | ||
| 60-6312 | In distribution | ||
| 42-1860 | In distribution | ||
| 42-1631 | In distribution | ||
| 60-7070 | In distribution | ||
| 60-6311 | In distribution | ||
| 55-8196 | In distribution | ||
| 42-2077 | In distribution | ||
| 22-8232 | In distribution | ||
| 42-1875C | In distribution | ||
| 22-8847 | In distribution | ||
| 42-1975 | In distribution | ||
| 22-8834 | In distribution | ||
| 21-805 | 12 | In distribution | |
| 42-1842 | In distribution | ||
| 42-1654 | In distribution | ||
| 42-1895 | In distribution | ||
| 47-2836 | In distribution | ||
| 22-8255C | In distribution | ||
| 60-6340 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 1,870 |
| Omni-Tract® | Integra Lifesciences Corporation | 347 |
| Mediflex Universal Round Bar Table Mounted Retractor Systems | Flexbar Machine Corp. | 271 |
| Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 209 |
| Pilling | Teleflex Medical LLC | 184 |
| Hayden Medical | Hayden Medical Inc | 172 |
| V. Mueller | Steris Corporation | 158 |
| Ambler Surgical | Ambler Surgical, LLC | 118 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 115 |
| Aesculap | Aesculap AG | 107 |
| Mini-Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 105 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 56 |
Showing 12 of 178. All products under Retractor, Self-Retaining
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. | 75 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.