Centurion
Sterile Sims Uterine Curette #2 (SUC102)
11manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Jiangsu (3), Shandong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | HTF |
| Device type | Curette |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-01-01 |
| Record revised | 2025-07-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I68060 | In distribution | |
| I68525 | In distribution | |
| 67055 | In distribution | |
| I68330K | In distribution | |
| I68635 | In distribution | |
| I68480 | In distribution | |
| I68070 | In distribution | |
| I68345K | In distribution | |
| 67050 | In distribution | |
| I67775 | In distribution | |
| I86575 | In distribution | |
| 67050 | In distribution | |
| 67760 | In distribution | |
| 67600 | In distribution | |
| 66745 | In distribution | |
| 67430 | In distribution | |
| I68055 | In distribution | |
| 66745 | In distribution | |
| I68330 | In distribution | |
| 67755 | In distribution | |
| NSBCE463004 | In distribution | |
| I68340K | In distribution | |
| I68470 | In distribution | |
| I67600K | In distribution | |
| I68340 | In distribution | |
| I68040 | In distribution | |
| 67600K | In distribution | |
| I68345 | In distribution | |
| I68350 | In distribution | |
| I67970 | In distribution | |
| 67600K | In distribution | |
| I67770 | In distribution | |
| I68335 | In distribution | |
| I86905 | In distribution | |
| 67600 | In distribution | |
| 67395 | In distribution | |
| I68380 | In distribution | |
| 67395K | In distribution | |
| 67055 | In distribution | |
| 67750 | In distribution | |
| I68050 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthomed | Ortho-MED, Inc. | 341 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 276 |
| General Instruments | Alphatec Spine, Inc. | 252 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 242 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 240 |
| Millennium | Avalign Technologies, Inc. | 233 |
| Curette | Depuy Spine, Inc. | 203 |
| Curette | George Tiemann & Co. | 179 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 135 |
| Battalion | Alphatec Spine, Inc. | 131 |
| Ambler Surgical | Ambler Surgical, LLC | 129 |
| Curette | Synthes Gmbh | 127 |
Showing 12 of 258. All products under Curette
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-12 | Class II | Process control | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. | 21,440 total |
| Medline Industries, LP – Northfield | UDI-DI | 2024-02-23 | Class II | Process control | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. | 20614 units |
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.