Subtle Cannula With Guide
40cm Cannula with Guide
14manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Atricure, Inc., United States |
|---|---|
| FDA product code | GEA |
| Device type | Cannula, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K120857 |
| Record published | 2021-01-08 |
| Record revised | 2022-06-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box, case of 50 |
| Sizes | Length 30 to 40 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSK-6140 | Length 40 cm | In distribution |
| CSK-6140 | Length 40 cm | In distribution |
| CSK-6130 | Length 30 cm | In distribution |
| CSK-6130 | Length 30 cm | 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
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.