Level ONE Transbuccal
Cannula, Clock, Tlts, FOR Double Threaded Plates AND 50-501-XX
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 | KLS-Martin L.P., 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2026-01-13 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50-501-19-07 | 48 MM | In distribution |
| 99-569-53-01 | 58 MM | In distribution |
| 25-472-20-07 | 38 MM | In distribution |
| 50-501-05-07 | 60 MM | In distribution |
| 96-472-20-07 | 48 MM | In distribution |
| 01-501-07-07 | In distribution | |
| 50-501-17-07 | 48 MM | In distribution |
| 99-569-53-02 | 70 MM | In distribution |
| 24-015-56-07 | 113 MM | In distribution |
| 50-501-36-07 | 61 MM | In distribution |
| 50-501-14-07 | 57 MM | In distribution |
| 99-569-97-02 | 100 MM | In distribution |
| 01-961-19-07 | 65 MM | In distribution |
| 995-3903-01 | 48 MM | In distribution |
| 50-501-71-07 | 48 MM | In distribution |
| 24-015-57-07 | 100 MM | In distribution |
| 50-501-15-07 | 48 MM | In distribution |
| 01-100-96-07 | In distribution | |
| 25-479-10-07 | In distribution | |
| 50-501-16-07 | 48 MM | In distribution |
| 25-471-05-07 | 33 MM | In distribution |
| 25-471-15-07 | 47 MM | In distribution |
| 01-501-40-07 | In distribution | |
| 99-569-97-01 | 113 MM | In distribution |
| 01-501-05-07 | In distribution | |
| 50-501-42-07 | 55 MM | In distribution |
| 50-501-06-07 | 48 MM | In distribution |
| 50-317-00-07 | In distribution | |
| 01-501-09-07 | 71 MM | In distribution |
| 50-501-01-07 | 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.