Sklar
Censitrac Ready Lancaster EYE Speculum 3 1/4 IN
11manufacturers in China registered for this device type
121catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Shandong (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 |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HNC |
| Device type | Specula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-10 |
| Record revised | 2019-09-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 65-1045 | In distribution | ||
| 65-1429 | In distribution | ||
| 96-3809 | 10 | In distribution | |
| 65-7690 | In distribution | ||
| 65-1744 | In distribution | ||
| 65-1756 | In distribution | ||
| 65-1043 | In distribution | ||
| 96-3806 | 10 | In distribution | |
| 65-1020 | In distribution | ||
| 65-1680 | In distribution | ||
| 82030 | In distribution | ||
| 65-1754 | In distribution | ||
| 65-1750 | In distribution | ||
| 96-3829 | 10 | In distribution | |
| 65-1532 | In distribution | ||
| 82095 | In distribution | ||
| 65-1432 | In distribution | ||
| 65-1536 | In distribution | ||
| 82045 | In distribution | ||
| 96-3823 | 10 | In distribution | |
| 82005 | In distribution | ||
| 82015 | In distribution | ||
| 82025 | In distribution | ||
| 96-3801 | 10 | In distribution | |
| 96-3830 | 10 | In distribution | |
| 82060 | In distribution | ||
| 96-3803 | 10 | In distribution | |
| 65-1624 | In distribution | ||
| 65-1800 | In distribution | ||
| 65-1026 | In distribution | ||
| 65-7685 | In distribution | ||
| 65-1040 | In distribution | ||
| 96-3804 | 10 | In distribution | |
| 65-1540 | In distribution | ||
| 65-1676 | In distribution | ||
| 82100 | In distribution | ||
| 65-1532C | In distribution | ||
| 96-3822 | 10 | In distribution | |
| 65-7698 | In distribution | ||
| 65-1538 | In distribution | ||
| 65-1042 | In distribution | ||
| 65-7680 | In distribution | ||
| 82010 | In distribution | ||
| 65-1765 | In distribution | ||
| 82035 | In distribution | ||
| 65-7677 | In distribution | ||
| 82021 | In distribution | ||
| 96-3817 | 10 | In distribution | |
| 96-3825 | 10 | In distribution | |
| 65-1528 | In distribution | ||
| 65-1677 | In distribution | ||
| 65-1029 | In distribution | ||
| 65-1766 | In distribution | ||
| 65-1608 | In distribution | ||
| 65-1332 | In distribution | ||
| 82065 | In distribution | ||
| 65-1435 | In distribution | ||
| 96-3827 | 10 | In distribution | |
| 65-1679 | In distribution | ||
| 82070 | In distribution | ||
| 65-7678 | In distribution | ||
| 65-1424 | In distribution | ||
| 65-1550 | In distribution | ||
| 65-1552 | In distribution | ||
| 65-7697 | In distribution | ||
| 65-1678 | In distribution | ||
| 65-7682 | In distribution | ||
| 65-1742 | In distribution | ||
| 65-1529 | In distribution | ||
| 65-1031 | In distribution | ||
| 96-3810 | 10 | In distribution | |
| 65-1427 | In distribution | ||
| 67-6138 | In distribution | ||
| 65-1426 | In distribution | ||
| 65-7696 | In distribution | ||
| 65-1022 | In distribution | ||
| 82040 | In distribution | ||
| 65-7683 | In distribution | ||
| 82050 | In distribution | ||
| 96-3820 | 10 | In distribution | |
| 82000 | In distribution | ||
| 65-1730 | In distribution | ||
| 65-1758 | In distribution | ||
| 65-1430 | In distribution | ||
| 65-1433 | In distribution | ||
| 65-1024 | In distribution | ||
| 65-1756C | In distribution | ||
| 65-1522 | In distribution | ||
| 65-1535 | In distribution | ||
| 65-1760 | In distribution | ||
| 65-1030 | In distribution | ||
| 65-1626 | In distribution | ||
| 65-7695 | In distribution | ||
| 65-1527 | In distribution | ||
| 65-1530 | In distribution | ||
| 82080 | In distribution | ||
| 96-3818 | 10 | In distribution | |
| 65-1041 | In distribution | ||
| 96-3800 | 10 | In distribution | |
| 82023 | In distribution | ||
| 65-7679 | In distribution | ||
| 96-3824 | 10 | In distribution | |
| 65-7684 | In distribution | ||
| 82075 | In distribution | ||
| 65-1044 | In distribution | ||
| 65-1431 | In distribution | ||
| 82090 | In distribution | ||
| 65-1623 | In distribution | ||
| 65-1012 | In distribution | ||
| 96-3821 | 10 | In distribution | |
| 65-7688 | In distribution | ||
| 65-1127 | In distribution | ||
| 65-1625 | In distribution | ||
| 96-3808 | 10 | In distribution | |
| 82020 | In distribution | ||
| 65-1028 | In distribution | ||
| 65-1425 | In distribution | ||
| 82085 | In distribution | ||
| 65-1545 | In distribution | ||
| 65-1740 | In distribution | ||
| 65-1227 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 214 |
| Ambler Surgical | Ambler Surgical, LLC | 169 |
| Walcott Rx Products | Walcott Rx Product Inc | 115 |
| Ophthalmic Speculum | Aurora Surgical, LLC | 93 |
| MR Phaco | Crestpoint Management Ltd. | 84 |
| Millennium | Avalign Technologies, Inc. | 79 |
| Ophthalmic Speculum | Katena Products, Inc. | 76 |
| Stephens Instruments | Krishna Imports Inc | 61 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 55 |
| Surtex | Surtex Instruments Ltd | 54 |
| Rumex | Rumex International Co. | 47 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 38 |
Showing 12 of 360. All products under Specula, Ophthalmic
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. | 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.