Medetz Surgical Instruments
Gimbel-Mendez Beveled Degree Gauge with teeth, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Round Knurled Handle, 117mm Overall Length, Titanium (with…
Gimbel-Mendez Beveled Degree Gauge with teeth, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Round Knurled Handle, 117mm Overall Length, Titanium (with Stainless color)
Who Else Makes It
Concentrated in Shanghai (2), Beijing (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Hilsinger Trading (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 4 |
Record
| Listed by | Medetz Surgical Instruments, United States |
|---|---|
| FDA product code | HLF |
| Device type | Device, Measuring, Lens Radius, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1430 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-23 |
| Record revised | 2023-06-16 (version 3) |
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 |
|---|---|---|
| 11-1310 | In distribution | |
| m11-1310 | In distribution | |
| 14-0125-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
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| LRI/Toric Markers | Aurora Surgical, LLC | 13 |
| Corneal Markers | Aurora Surgical, LLC | 12 |
| LASIK Cannulas | Aurora Surgical, LLC | 11 |
| PRK, LASIK, Lasek, IntraLasik and Flap Management Instruments | Aurora Surgical, LLC | 11 |
| Hoffer Optical Zone Marker | Aurora Surgical, LLC | 9 |
| Dsek Markers | Aurora Surgical, LLC | 4 |
| Lasik Markers | Aurora Surgical, LLC | 3 |
| Centration Marker | Aurora Surgical, LLC | 3 |
| Hoffer Optical Zone Marker, With Cross Hairs, 4mm, Titanium | Aurora Surgical, LLC | 2 |
| Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titaniu | Aurora Surgical, LLC | 2 |
| Corneal Transplant Markers | Aurora Surgical, LLC | 2 |
| Lasek Instruments | Aurora Surgical, LLC | 2 |
Showing 12 of 49. All products under Device, Measuring, Lens Radius, 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.