Curette
Singer Sweep, Left Hand Dominant Surgeon
8manufacturers in China registered for this device type
28catalogue 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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNZ |
| Device type | Curette, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-16 |
| Record revised | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Lumen/inner diameter 1 to 3.5 mm; outer diameter 1.5 to 3.5 mm; angle 360 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08-13230 | Angle 360 ° | In distribution |
| 08-06101 | Size 00 | In distribution |
| K3-1030 | Outer Diameter 2.5 mm | In distribution |
| K3-1040 | Size 4 | In distribution |
| 08-06105 | Lumen/Inner Diameter 2.5 mm | In distribution |
| 08-06104 | Lumen/Inner Diameter 2 mm | In distribution |
| 08-13215 | In distribution | |
| K3-1100 | In distribution | |
| K3-1105 | In distribution | |
| 08-06103 | Size 1 | In distribution |
| 08-06106 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 08-13214 | In distribution | |
| 08-06102 | Lumen/Inner Diameter 1.5 mm | In distribution |
| 08-07159L | In distribution | |
| K3-1020 | Outer Diameter 2.25 mm | In distribution |
| 08-13229 | In distribution | |
| 08-01305 | In distribution | |
| K3-1104 | In distribution | |
| 08-07158 | In distribution | |
| K3-1010 | Outer Diameter 1.75 mm | In distribution |
| 08-13215D | In distribution | |
| K3-1102 | In distribution | |
| K3-1111 | In distribution | |
| K3-1103 | In distribution | |
| 87-06105 | Size 3 | In distribution |
| 08-07159R | In distribution | |
| 87-06102 | Size 0 | In distribution |
| K3-1000 | Outer Diameter 1.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 32 |
| 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 |
| Sklar® | Sklar 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.