Ear and Ulcer Syringe
Ear and Ulcer Syringe, 2 oz., with Broad Tip, Bulk
110manufacturers in China registered for this device type
12catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (31), Guangdong (27), Zhejiang (26). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
Showing 12 of 110. All 110 manufacturers in China registered for Syringe, Irrigating (Non Dental)
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | KYZ |
| Device type | Syringe, Irrigating (Non Dental) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6960 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-21 |
| Record revised | 2020-12-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50, case of 24, case of 12 |
| Sizes | Total volume 1 to 3 Fluid Ounce |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0935830 | Total Volume 3 Fluid Ounce | 150 | In distribution |
| 9005270 | Total Volume 2 Fluid Ounce | 200 | In distribution |
| 0935810 | Total Volume 1 Fluid Ounce | 300 | In distribution |
| 0035810 | Total Volume 1 Fluid Ounce | In distribution | |
| 0035820 | Total Volume 2 Fluid Ounce | In distribution | |
| 0005260 | Total Volume 1 Fluid Ounce | In distribution | |
| 0035830 | Total Volume 3 Fluid Ounce | In distribution | |
| 9005290 | Total Volume 3 Fluid Ounce | 150 | In distribution |
| 0005270 | Total Volume 2 Fluid Ounce | In distribution | |
| 0005290 | Total Volume 3 Fluid Ounce | In distribution | |
| 9005260 | Total Volume 1 Fluid Ounce | 300 | In distribution |
| 9035820 | Total Volume 3 Fluid Ounce | 200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| FibriJet | Micromedics, Inc. | 35 |
| LSL Healthcare | Lsl Industries, Inc. | 24 |
| Medline | Medline Industries, Inc. | 21 |
| Baria | Shenzhen Baria Technology Co., Ltd. | 20 |
| Monoject | Cardinal Health 200, LLC | 17 |
| Centurion | Centurion Medical Products Corporation | 17 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 14 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 12 |
| Cardinal Health | Cardinal Health 200, LLC | 12 |
| Nordson Medical | Micromedics, Inc. | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 9 |
| Rospital Productos Medicos | Atlas Medical Products LLC | 9 |
Showing 12 of 129. All products under Syringe, Irrigating (Non Dental)
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-08-03 | Class II | Process control | Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. | 452,728 units | 2021-10-05 |
| 2016-08-03 | Class II | Process control | Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. | 2021-10-05 | |
| 2016-08-03 | Class II | Process control | Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. | 2021-10-05 | |
| 2016-08-03 | Class II | Process control | Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. | 2021-10-05 | |
| 2016-01-04 | Class III | Packaging process control | Report by a customer of an open package seal. | 15,400 units | 2017-06-06 |
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.