Ambler Surgical
Peregrine DMEK donor tissue spoon, 4 3/4'', angled shaft, smooth 9.0mm diameter, dual notches, round handle, designed to hold the donor tissue prior to the surgeon pulling it into the eye
7manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Liaoning (2), Shanghai (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Muling City Long SEN Wood Products Ltd. | Mudanjiang | Heilongjiang | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian | Liaoning | Contract manufacturer | 15 |
Record
| Listed by | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HNB |
| Device type | Spoon, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Paton double-ended spoon/spatula | In distribution | |
| Bunge evisceration spoon | In distribution | |
| Rosenwasser lamellar donor shovel | In distribution | |
| Wells enucleation spoon | In distribution | |
| Bunge evisceration spoon | In distribution | |
| Fisher spoon and needle | In distribution | |
| Peregrine DMEK donor tissue spoon | In distribution | |
| Knapp/Culler lens spoon | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ophthalmic Spoon | Katena Products, Inc. | 27 |
| Opthalmic Spoon | Ovation International | 21 |
| Sklar | Sklar Corporation | 11 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 11 |
| Spoon, Ophthalmic | Geuder Aktiengesellschaft | 10 |
| V. Mueller | Steris Corporation | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 9 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 7 |
| gSource | Gsource, LLC. | 7 |
| Medetz Surgical Instruments | Medetz Surgical Instruments | 7 |
| Bunge Evisceration Spoon | Sontec Instruments, Inc. | 6 |
| Hayden Medical | Hayden Medical Inc | 4 |
Showing 12 of 41. All products under Spoon, 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.