Sklar®
Censitrac Ready Andrews-Pynchon Suct Tube 9.25
Who Else Makes It
Concentrated in Zhejiang (7), Shanghai (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Kindly Enterprise Development Group Co., Ltd. | Jiading | Shanghai | Contract manufacturer | 11 |
| 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 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Ningbo Hanyue Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 27 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Showing 12 of 14. All 14 manufacturers in China registered for Cannula, Surgical, General & Plastic Surgery
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | GEA |
| Device type | Cannula, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-24 |
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 |
|---|---|---|
| 07-1806 | In distribution | |
| 22-6586 | In distribution | |
| 07-1830 | In distribution | |
| 07-1820 | In distribution | |
| 07-1832 | In distribution | |
| 07-1801 | In distribution | |
| 22-6585 | In distribution | |
| 07-1850 | In distribution | |
| 22-6590C | In distribution | |
| 07-1831 | In distribution | |
| 22-6590 | In distribution | |
| 07-1807 | In distribution | |
| 07-1805 | In distribution | |
| 07-1802 | In distribution | |
| 22-6585C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | Black & Black Surgical, Inc. | 1,600 |
| Summit Medical | Summit Medical LLC | 988 |
| Medco Manufacturing | Medco Manufacturing LLC | 562 |
| Hayden Medical | Hayden Medical Inc | 457 |
| Cannula, Surgical, General & Plastic Surgery | Shippert Medical Technologies Corp. | 452 |
| Boss Instruments | Boss Instruments, Ltd. | 436 |
| Millennium | Avalign Technologies, Inc. | 281 |
| Black & Black Surgical | Black & Black Surgical, Inc. | 227 |
| Alira Medical Devices | Alira Medical Devices LLC | 157 |
| Black & Black Surgical, Inc. | Black & Black Surgical, Inc. | 154 |
| Aesculap | Aesculap AG | 134 |
| Euromi | Euromi | 126 |
Showing 12 of 608. All products under Cannula, Surgical, General & Plastic Surgery
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. | 150 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.