Novo Surgical Inc.
kelly decemet punch, produces a precise 0.75 nn riybd gike w/ out tissue tags, serrated squeeze handle
3manufacturers in China registered for this device type
2catalogue 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 | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | HNJ |
| Device type | Punch, Corneo-Scleral |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP7121-18 | In distribution | |
| OP7121-11 | 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 |
| Trab. Punch | Katena Products, Inc. | 7 |
| 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 |
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.