TissueGUARD
The TissueGUARD DMEK Injector SET is a sterile, single-use system for Descemet Membrane Endothelial Keratoplasty (DMEK), in which a human donor graft of Descemet's membrane with endothelium…
The TissueGUARD DMEK Injector SET is a sterile, single-use system for Descemet Membrane Endothelial Keratoplasty (DMEK), in which a human donor graft of Descemet’s membrane with endothelium is transplanted subsequent to the removal of the recipient’s Descemet’s membrane. The TissueGUARD DMEK INJECTOR SET can be used for DMEK in children, adolescents, and adults. The main part of the system is an ophthalmic cannula with corresponding supporting accessories.
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Shandong (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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
Record
| Listed by | TissueGUARD, Germany |
|---|---|
| FDA product code | HMX |
| Device type | Cannula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment temperature 50 to 86 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DMEK Injector SET | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 909 |
| Walcott Rx Products | Walcott Rx Product Inc | 663 |
| MR Phaco | Crestpoint Management Ltd. | 625 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 511 |
| Ambler Surgical | Ambler Surgical, LLC | 447 |
| Millennium | Avalign Technologies, Inc. | 270 |
| Ophthalmic Cannula | Katena Products, Inc. | 251 |
| Surgistar | Surgistar, Inc. | 179 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 137 |
| Walcott Rx Products | Psi/Eye-Ko, Inc. | 133 |
| Surgical Direct | Surgical Direct, Inc. | 127 |
| Visitec® | Beaver-Visitec International, Ltd | 124 |
Showing 12 of 1,064. All products under Cannula, Ophthalmic
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.