Wire Speculum
Wire Speculum Closed Blades 18 Millimeter Spread With Right Third Eyelid Blade Titanium
11manufacturers in China registered for this device type
16catalogue 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 | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | HNC |
| Device type | Specula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2020-06-24 |
| Record revised | 2026-03-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 4 to 65 mm |
| Distribution end date | 2025-12-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-1000C-13 | Blades: 10 Millimeter Spread | In distribution |
| T10-1014 | Blade Length 10.0 Millimeter | In distribution |
| 10-1345 | Length 20 mm | In distribution |
| T10-1720 | Length 65 mm | In distribution |
| 10-1330 | 3 Millimeter Blades | In distribution |
| 10-1015 | Blade Length: 14 Millimeter | In distribution |
| 10-1320 | 2 Millimeter Blades | In distribution |
| T10-1013 | Blade Spread 18.0 Millimeter | In distribution |
| 10-1360H | Length 8 mm | In distribution |
| 10-1360 | Length 8 mm | In distribution |
| 10-1010C-08 | Length 39 mm | In distribution |
| 10-1350 | Length 4 mm | In distribution |
| T10-1016 | Blades 14 Millimeter | In distribution |
| T10-1015 | Blades 14 Millimeter | In distribution |
| 10-1016 | Blade Length: 14 Millimeters | In distribution |
| T10-1017 | Blade Length 10 Millimeter | Withdrawn |
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 |
| 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 |
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.