Mrk, Ocular
Dell Fixed Toric Mark. W/ Rotating Bezel
7manufacturers in China registered for this device type
26catalogue 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 | 2022-11-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Lumen/inner diameter 3 to 16 mm; angle 40 to 80 °; circumference 5.75 to 6 mm; length 6 to 8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08-15117 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 08-15123 | Lumen/Inner Diameter 5 mm | In distribution |
| 08-12108 | In distribution | |
| 08-12107 | In distribution | |
| 08-12117 | In distribution | |
| 08-12113 | In distribution | |
| 05-8214 | Circumference 5.75 mm | In distribution |
| 08-12111 | Angle 80 ° | In distribution |
| 08-15118 | Lumen/Inner Diameter 3.75 mm | In distribution |
| 08-16147 | In distribution | |
| 08-15128 | Lumen/Inner Diameter 11 mm | In distribution |
| 08-16160 | Lumen/Inner Diameter 16 mm | In distribution |
| 08-121115 | In distribution | |
| 08-12116 | In distribution | |
| 08-15260 | Lumen/Inner Diameter 8.75 mm | In distribution |
| 08-15124 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 08-121085 | Length 8 mm | In distribution |
| 08-15200 | In distribution | |
| 08-12119 | In distribution | |
| 08-15126 | Lumen/Inner Diameter 7 mm | In distribution |
| 08-15125 | Lumen/Inner Diameter 6 mm | In distribution |
| 08-15115 | Lumen/Inner Diameter 3 mm | In distribution |
| 08-12120 | In distribution | |
| 08-08233 | In distribution | |
| 08-12114 | In distribution | |
| 08-15127 | Lumen/Inner Diameter 8 mm | 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.