Marker, Ocular
Henderson Degree Gauge With Teeth
7manufacturers in China registered for this device type
51catalogue 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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HMR |
| Device type | Marker, Ocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-14 |
| Record revised | 2023-08-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Width 5.5 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K3-8414 | In distribution | |
| K3-8137 | In distribution | |
| K3-8412 | In distribution | |
| K3-8131 | In distribution | |
| K3-7720 | In distribution | |
| K3-8146 | In distribution | |
| K3-8422 | In distribution | |
| K3-7930 | In distribution | |
| K3-8142 | In distribution | |
| K3-8138 | In distribution | |
| K3-8154 | In distribution | |
| K3-7910 | In distribution | |
| K3-8132 | In distribution | |
| K3-8148 | In distribution | |
| K3-7850 | Width 6 mm | In distribution |
| K3-8150 | In distribution | |
| K3-8975 | In distribution | |
| K3-8340 | In distribution | |
| K3-7936 | In distribution | |
| K3-8133 | In distribution | |
| K3-8370 | In distribution | |
| K3-8862 | In distribution | |
| K3-8418 | In distribution | |
| K3-7852 | Width 5.5 mm | In distribution |
| K3-8426 | In distribution | |
| K3-8135 | In distribution | |
| K3-8380 | In distribution | |
| K3-8130 | In distribution | |
| K3-8855 | In distribution | |
| K3-7912 | In distribution | |
| K3-7737 | In distribution | |
| K3-7730 | In distribution | |
| K3-7996 | In distribution | |
| K3-7905 | In distribution | |
| K3-8330 | In distribution | |
| K3-8360 | In distribution | |
| K3-8410 | In distribution | |
| K3-8390 | In distribution | |
| K3-8977 | In distribution | |
| K3-7906 | In distribution | |
| K3-7900 | In distribution | |
| K3-8350 | In distribution | |
| K3-7904 | In distribution | |
| K3-8400 | In distribution | |
| K3-8852 | In distribution | |
| K3-8854 | In distribution | |
| K3-8136 | In distribution | |
| K3-8134 | In distribution | |
| K3-8101 | In distribution | |
| K3-8152 | In distribution | |
| K3-7908 | 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 |
| Surgical Direct | Surgical Direct, Inc. | 40 |
| Rumex | Rumex International Co. | 37 |
| Duckworth & Kent | Duckworth AND Kent Limited | 33 |
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 28 |
| 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.