Surgical Direct
Toric Marker, 11mm ID, 15mm OD, Marks 0 Degree to 180 Degree Increments, Labeled Every 30 Dregees, Head Mounted at 0 Degrees, Holes Every 90 Degrees, Titanium Round Handle
7manufacturers in China registered for this device type
40catalogue 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 | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | HMR |
| Device type | Marker, Ocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2024-04-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD93455612 | In distribution | |
| SD934541105 | In distribution | |
| SD93455710 | In distribution | |
| SD93455613 | In distribution | |
| SD93454302 | In distribution | |
| S34556.200T | In distribution | |
| SD934543100 | In distribution | |
| S34500.52 | In distribution | |
| S34541.102 | In distribution | |
| SD93454110 | In distribution | |
| S34557.100 | In distribution | |
| S490.100 | In distribution | |
| S34556.400T | In distribution | |
| SD934556101 | In distribution | |
| S34558.100 | In distribution | |
| S34547.200 | In distribution | |
| S34500.80 | In distribution | |
| S34541.02 | In distribution | |
| SD93428014 | In distribution | |
| S34547.100T | In distribution | |
| SD93454711 | In distribution | |
| SD934520100 | In distribution | |
| S34500.50 | In distribution | |
| S34500.51 | In distribution | |
| SD934541101 | In distribution | |
| S34016.100 | In distribution | |
| S6000.000 | In distribution | |
| S5616.02 | In distribution | |
| SD93455614 | In distribution | |
| SD93455012 | In distribution | |
| SD9S3455620T | In distribution | |
| S34541.103 | In distribution | |
| SD93455615 | In distribution | |
| S34291.100 | In distribution | |
| S34500.90 | In distribution | |
| SD934291100 | In distribution | |
| SD93450070 | In distribution | |
| S34556.14 | In distribution | |
| S34520.100 | In distribution | |
| S34556.201 | 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 |
| 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.