Epsilon USA
Mendez Degree Gauge 15mm x 1.0mm Mendez With New Bi-Manual Handle (115 mm overall) Titanium
7manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Hubei (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 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| 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 |
Record
| Listed by | Epsilon EYE Care PVT., Ltd., India |
|---|---|
| FDA product code | HMR |
| Device type | Marker, Ocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-21 |
| Record revised | 2023-07-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ET-26 | In distribution | |
| ET-29 | In distribution | |
| ET-39 | In distribution | |
| EC-149 5.75 | In distribution | |
| ET-16 | In distribution | |
| ET-01 | In distribution | |
| ET-17 | In distribution | |
| ET-02 | In distribution | |
| ET-03 | In distribution | |
| ET-05 | In distribution | |
| ET-25 | In distribution | |
| ET-12 | In distribution | |
| BP-01R | In distribution | |
| ET-10 | In distribution | |
| ET-30 | In distribution | |
| ET-01-90 | In distribution | |
| ET-04 | In distribution | |
| ET-20 | In distribution | |
| ET-32 | In distribution | |
| ET-15 | In distribution | |
| ET-22 | In distribution | |
| ET-18 | In distribution | |
| ET-21 | In distribution | |
| EC-149 6.0 | In distribution | |
| ET-28 | In distribution | |
| ET-31 | In distribution | |
| ET-11 | In distribution | |
| BP-01R SS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 196 |
| Walcott Rx Products | Walcott Rx Product Inc | 188 |
| Mastel Precision Surgical Instruments, Inc. | Mastel Surgical Inc. | 148 |
| MR Phaco | Crestpoint Management Ltd. | 125 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 122 |
| Millennium | Avalign Technologies, Inc. | 90 |
| Marker, Ocular | Katena Products, Inc. | 51 |
| Surgical Direct | Surgical Direct, Inc. | 40 |
| Rumex | Rumex International Co. | 37 |
| Duckworth & Kent | Duckworth AND Kent Limited | 33 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 27 |
| Mrk, Ocular | Katena Products, Inc. | 26 |
Showing 12 of 213. All products under Marker, Ocular
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.