ONE
12 catalogue numbers from ONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL, listed by Moria, Inc., France, under Marker, Ocular. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
12catalogue 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 | Moria, Inc., France |
|---|---|
| FDA product code | HMR |
| Device type | Marker, Ocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Premarket notification | Exempt |
| Record published | 2023-12-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 5, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL | In distribution | |
| ONE S- Corneal marker diameter 8mm X5 | In distribution | |
| ONE S- Corneal marker diameter 8mm X10 | In distribution | |
| ONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL | In distribution | |
| ONE-BORES MARKER, 12MM | In distribution | |
| ONE S- Corneal marker diameter 9mm X10 | In distribution | |
| ONE S-Scleral marker X20 | In distribution | |
| ONE S- Corneal marker diameter 8.5mm X10 | In distribution | |
| ONE S- Corneal marker diameter 8.5mm X5 | In distribution | |
| ONE S- Corneal marker diameter 9mm X5 | In distribution | |
| ONE S-Scleral marker X5 | In distribution | |
| ONE-BORES MARKER, 12MM | 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 |
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 28 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 27 |
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.