Scleral Marker
Gass Scleral Marker
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | HMQ |
| Device type | Marker, Sclera |
| 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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K1-7790 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stephens Instruments | Krishna Imports Inc | 61 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 31 |
| Malosa Medical | Beaver-Visitec International, Ltd | 2 |
| Braunstein Marker | Blink Medical Ltd | 1 |
| Marker Double Ended 3.5mm-4mm | Blink Medical Ltd | 1 |
| Thornton TWO RAY Meridian Marker | Sontec Instruments, Inc. | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
| Dual Tip Marker Pen – Methylene Blue | Hurricane Medical | 1 |
| Thornton Corneal Marker | Sontec Instruments, Inc. | 1 |
| Marker Pad – Methylene Blue | Hurricane Medical | 1 |
| Dual Tip Marker Pen – Gentian Violet | Hurricane Medical | 1 |
| Thorton Corneal Marker | Sontec Instruments, Inc. | 1 |
Showing 12 of 16. All products under Marker, Sclera
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.