Trab. Punch
Fukasaku Micro Trabeculectomy Punch
3manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (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 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNJ |
| Device type | Punch, Corneo-Scleral |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-16 |
| Record revised | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08-13000 | In distribution | |
| K2-9512 | In distribution | |
| K2-9505 | In distribution | |
| K2-9510 | In distribution | |
| K2-9525 | In distribution | |
| K2-9506 | In distribution | |
| K2-9500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ONE | Moria, Inc. | 46 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 33 |
| Moria | Moria, Inc. | 18 |
| Punches | Aurora Surgical, LLC | 14 |
| Ambler Surgical | Ambler Surgical, LLC | 8 |
| Millennium | Avalign Technologies, Inc. | 7 |
| Punch, Corneo-Scleral | Geuder Aktiengesellschaft | 6 |
| Trabeculotome | Aurora Surgical, LLC | 6 |
| Rumex | Rumex International Co. | 5 |
| Stephens Instruments | Krishna Imports Inc | 5 |
| V. Mueller | Steris Corporation | 3 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 3 |
Showing 12 of 33. All products under Punch, Corneo-Scleral
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.