Ambler Surgical
Iowa P.K. press punch, used for precise donor corneal button punching, designed for use with Ambler long trephines (33-0600 to 33-1200), includes two cutting blocks (Ambler # 7246E)
3manufacturers in China registered for this device type
8catalogue 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 | Ambler Surgical, LLC, 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 | 2021-01-04 |
| Record revised | 2022-11-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Southern eye bank of New Orleans cutting block | In distribution | |
| Anis scleral twist fixation cone | In distribution | |
| Iowa P.K. press punch | In distribution | |
| Luntz-Dodick trabeculectomy punch | In distribution | |
| Kelly decemet membrane punch | In distribution | |
| Gass corneoscleral punch | In distribution | |
| Iowa P.K. press punch | In distribution | |
| Castroviejo corneoscleral punch | 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 |
| 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 |
| 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.