SuperDART® ONE Pass™ Validated Channel Cleaning Device
Brush Cleaning 3 TO 4.5MM X 240CM Multi Action Pull Through Squeegee. Hibc/UPN: M45392932
43manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (8), Guangdong (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Hangzhou Aosi Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 18 |
| Suzhou Suning Underpad Co., Ltd. | Suzhou, Jiangsu Province | Contract manufacturer | 11 | |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| Xinle Huabao Medical Products Co., Ltd. | Xinle | Hebei | Contract manufacturer | 2 |
| Dongguan Liangyou Electronic Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Showing 12 of 43. All 43 manufacturers in China registered for Accessories, Cleaning Brushes, For Endoscope
Record
| Listed by | Primed Instruments, Inc., Canada |
|---|---|
| FDA product code | MNL |
| Device type | Accessories, Cleaning Brushes, For Endoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9293 | Range of Channel Size: 2.0-2.8mm | 25 | In distribution |
| 9253 | Range of Channel Size: 2.0-2.8mm | 25 | In distribution |
| 9233 | Range of Channel Size: 2.0-2.8mm | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endo Carry-On Procedure Kit | Medivators Inc | 1,263 |
| Custom Procedure Kit | Medivators Inc | 433 |
| Compliance EndoKit™ | Boston Scientific Corporation | 404 |
| Trial Procedure Kit | Medivators Inc | 403 |
| Accessories, Cleaning Brushes, For Endoscope | Steris Corporation | 174 |
| Key Surgical Endoscope Brushes | Key Surgical, LLC | 121 |
| Accessories, Cleaning Brushes, For Endoscope | Key Surgical, LLC | 97 |
| Cygnus | Aspen Surgical Products, Inc. | 56 |
| Accessories, Cleaning Brushes, For Endoscope | Karl Storz GmbH & Co. KG | 49 |
| 9000 Series Disposable Channel Cleaning Brush | Primed Instruments, Inc. | 47 |
| Medline | Medline Industries, Inc. | 45 |
| Endoscope Brushes | Healthmark Industries Co., Inc. | 34 |
Showing 12 of 465. All products under Accessories, Cleaning Brushes, For Endoscope
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.