Millennium
Lester-Burch Eye Speculum, Screw Style Adjustment; Lay over the Temporal, 20mm Solid Blade, 30mm + Blade Spread, 38mm Total Length, Stainless Steel
11manufacturers in China registered for this device type
79catalogue numbers in this listing
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 | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | HNC |
| Device type | Specula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-17 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 85-170 | In distribution | |
| 85-72039142 | In distribution | |
| 86-8 | In distribution | |
| 92-15678 | In distribution | |
| 92-15012 | In distribution | |
| 85-118 | In distribution | |
| 3-4056 | In distribution | |
| 85-72038846 | In distribution | |
| 4-15680 | In distribution | |
| 92-S0110NV | In distribution | |
| 3-4055 | In distribution | |
| 92-S0025 | In distribution | |
| 86-4 | In distribution | |
| 92-4106T | In distribution | |
| 92-N2010C | In distribution | |
| 85-72039006 | In distribution | |
| 4-15671 | In distribution | |
| 92-S0118TR | In distribution | |
| 86-7 | In distribution | |
| 85-72038874 | In distribution | |
| 4-15955 | In distribution | |
| 92-S0117TR | In distribution | |
| 92-4057 | In distribution | |
| 1-1834 | In distribution | |
| 86-3 | In distribution | |
| 86-5 | In distribution | |
| 92-S0110NVT | In distribution | |
| 3-4073 | In distribution | |
| 92-S0116T | In distribution | |
| 86-2 | In distribution | |
| 3-4072 | In distribution | |
| 4-15678 | In distribution | |
| 85-71036934 | In distribution | |
| 92-S010514TS | In distribution | |
| 92-117 | In distribution | |
| 85-72039126 | In distribution | |
| 92-S0110TK10 | In distribution | |
| 3-4112 | In distribution | |
| 3-4082 | In distribution | |
| 3-4051 | In distribution | |
| 3-4105 | In distribution | |
| 92-S0110NSV12 | In distribution | |
| 85-72038902 | In distribution | |
| 92-S0124 | In distribution | |
| 92-N2020LC | In distribution | |
| 4-15012 | In distribution | |
| 85-72039030 | In distribution | |
| 4-15179 | In distribution | |
| 86-1 | In distribution | |
| 92-S0203 | In distribution | |
| 85-167 | In distribution | |
| 3-4107P | In distribution | |
| 86-9 | In distribution | |
| 92-S0126N/V | In distribution | |
| 3-4050 | In distribution | |
| 92-S0027 | In distribution | |
| 92-S0110SK | In distribution | |
| 10-350090 | In distribution | |
| 3-4080 | In distribution | |
| 86-6 | In distribution | |
| 4-15175 | In distribution | |
| 3-4086 | In distribution | |
| 92-15681 | In distribution | |
| 4-15675 | In distribution | |
| 85-72039042 | In distribution | |
| 92-4065A | In distribution | |
| 92-S010014TS | In distribution | |
| 86-169 | In distribution | |
| 3-4041 | In distribution | |
| 85-117 | In distribution | |
| 85-168 | In distribution | |
| 3-4108S | In distribution | |
| 3-4106KT | In distribution | |
| 92-808148 | In distribution | |
| 4-15171 | In distribution | |
| 85-72038882 | In distribution | |
| 3-4094 | In distribution | |
| 4-15702 | In distribution | |
| 3-4040 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 214 |
| Ambler Surgical | Ambler Surgical, LLC | 169 |
| Sklar | Sklar Corporation | 121 |
| Walcott Rx Products | Walcott Rx Product Inc | 115 |
| Ophthalmic Speculum | Aurora Surgical, LLC | 93 |
| MR Phaco | Crestpoint Management Ltd. | 84 |
| 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
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.