Sklar®
Hebra Chalaz Curette Oval 3.5M
8manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (1), Shandong (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 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HNZ |
| Device type | Curette, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-02-14 |
| Record revised | 2019-06-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 65-3181 | In distribution | |
| 65-3186 | In distribution | |
| 65-3173 | In distribution | |
| 65-3180 | In distribution | |
| 65-3169 | In distribution | |
| 65-3182 | In distribution | |
| 65-3184 | In distribution | |
| 65-3171 | In distribution | |
| 65-3170 | In distribution | |
| 65-3188 | In distribution | |
| 65-3185 | In distribution | |
| 65-3189 | In distribution | |
| 65-3187 | In distribution | |
| 65-3162 | In distribution | |
| 65-3172 | In distribution | |
| 65-3183 | In distribution | |
| 65-3174 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 32 |
| Curette | Katena Products, Inc. | 28 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 24 |
| Walcott Rx Products | Walcott Rx Product Inc | 21 |
| Stephens Instruments | Krishna Imports Inc | 21 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 17 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 16 |
| Millennium | Avalign Technologies, Inc. | 16 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 11 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 11 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 10 |
| Meyerhoefer-Chalazion Curette | Sontec Instruments, Inc. | 10 |
Showing 12 of 54. All products under Curette, 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.