Sklar®
Censitrac Ready Lounsbury Curette 13" 3/4" WD
8manufacturers in China registered for this device type
85catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Anhui Dajiang Medical Products Co., Ltd. | Chuzhou | Anhui | Manufacturer | 12 |
| Zhangzhou Aoxi Plastic Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 7 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HCY |
| Device type | Curette, Uterine |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-28 |
| Record revised | 2019-09-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 90-5605 | In distribution | ||
| 90-5603 | In distribution | ||
| 90-5624 | In distribution | ||
| 90-5432 | In distribution | ||
| 90-5607 | In distribution | ||
| 90-5424C | In distribution | ||
| 90-5473 | In distribution | ||
| 90-5461 | In distribution | ||
| 90-5436 | In distribution | ||
| 90-6272 | In distribution | ||
| 90-6274 | In distribution | ||
| 90-5434C | In distribution | ||
| 90-5617 | In distribution | ||
| 90-5614 | In distribution | ||
| 90-6285 | In distribution | ||
| 90-5469 | In distribution | ||
| 90-6083 | In distribution | ||
| 90-5450 | In distribution | ||
| 90-5613 | In distribution | ||
| 90-6081 | In distribution | ||
| 90-5425 | In distribution | ||
| 90-5440 | In distribution | ||
| 90-5421 | In distribution | ||
| 90-5474 | In distribution | ||
| 90-6275 | In distribution | ||
| 90-5633 | In distribution | ||
| 90-5604 | In distribution | ||
| 90-6195 | In distribution | ||
| 90-5627 | In distribution | ||
| 90-5499 | In distribution | ||
| 90-5615 | In distribution | ||
| 90-5472 | In distribution | ||
| 90-5722 | In distribution | ||
| 90-5433 | In distribution | ||
| 90-5618 | In distribution | ||
| 90-5500 | In distribution | ||
| 90-5465 | In distribution | ||
| 90-6271 | In distribution | ||
| 90-5623 | In distribution | ||
| 90-5431 | In distribution | ||
| 90-5606 | In distribution | ||
| 90-5423 | In distribution | ||
| 90-6270 | In distribution | ||
| 90-6084 | In distribution | ||
| 90-5466 | In distribution | ||
| 90-5611 | In distribution | ||
| 90-5471 | In distribution | ||
| 90-5424 | In distribution | ||
| 90-5626 | In distribution | ||
| 90-5612 | In distribution | ||
| 90-5434 | In distribution | ||
| 90-5476 | In distribution | ||
| 90-5622 | In distribution | ||
| 90-5462 | In distribution | ||
| 90-5470 | In distribution | ||
| 90-5435 | In distribution | ||
| 90-5475 | In distribution | ||
| 90-5629 | In distribution | ||
| 90-5619 | In distribution | ||
| 90-6273 | In distribution | ||
| 90-5625 | In distribution | ||
| 90-6289 | In distribution | ||
| 90-5610 | In distribution | ||
| 90-5620 | In distribution | ||
| 90-5438 | 6 | In distribution | |
| 90-5616 | In distribution | ||
| 90-5630 | In distribution | ||
| 90-5428 | 6 | In distribution | |
| 90-5715 | In distribution | ||
| 90-5713C | In distribution | ||
| 90-5566 | In distribution | ||
| 90-5463 | In distribution | ||
| 90-5632 | In distribution | ||
| 90-5713C | In distribution | ||
| 90-5464 | In distribution | ||
| 90-6082 | In distribution | ||
| 90-5422 | In distribution | ||
| 90-5621 | In distribution | ||
| 90-5720 | In distribution | ||
| 90-5602 | In distribution | ||
| 90-5426C | In distribution | ||
| 90-5628 | In distribution | ||
| 90-5426 | In distribution | ||
| 90-6095 | In distribution | ||
| 90-5710 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 1,021 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 118 |
| Aesculap | Aesculap AG | 105 |
| Millennium | Avalign Technologies, Inc. | 78 |
| Hayden Medical | Hayden Medical Inc | 68 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 67 |
| Novo Surgical | Novo Surgical, Inc. | 50 |
| Ambler Surgical | Ambler Surgical, LLC | 37 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 36 |
| V. Mueller | Steris Corporation | 34 |
| MedGyn Uterine Curette | Medgyn Products, Inc. | 33 |
| Gynex | Gynex Corporation | 31 |
Showing 12 of 59. All products under Curette, Uterine
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 0 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.