Pilling
Strongeur Suction Irrigator
24manufacturers in China registered for this device type
2catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (7), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| 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 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Showing 12 of 24. All 24 manufacturers in China registered for Catheter, Irrigation
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GBX |
| Device type | Catheter, Irrigation |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2021-01-20 (version 4) |
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, manufacturing date |
| Sizes | Length 9 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN007880 | Length 9 in | In distribution |
| IPN007880 | Length 9 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| One-Step™ | Merit Medical Systems, Inc. | 167 |
| Cardinal Health | Cardinal Health 200, LLC | 109 |
| Cook | Cook Incorporated | 85 |
| ReSolve® | Merit Medical Systems, Inc. | 68 |
| Pleur-Evac | Teleflex Medical LLC | 66 |
| Jackson-Pratt | Cardinal Health 200, LLC | 47 |
| Total Abscession | AngioDynamics, Inc. | 36 |
| Channel Drain | C.R. Bard, Inc. | 36 |
| ReSolve Mini™ | Merit Medical Systems, Inc. | 32 |
| Silicone Tubing, Radiopaque | Bentec Medical OpCo, LLC. | 25 |
| Blake | Ethicon, Inc. | 19 |
| Silicone Tubing, Translucent | Bentec Medical OpCo, LLC. | 19 |
Showing 12 of 223. All products under Catheter, Irrigation
Recalls
2 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2021-02-12 | Class II | Under Investigation by firm | Teleflex is recalling this product due to a lack of assurance of sterility. | 520 units (US only) | 2026-07-10 |
| 2020-08-07 | Class II | Under Investigation by firm | Potential sterility issue | 700 eaches | 2023-01-14 |
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.