Stradis Healthcare
Sterile Separatesl Specialties Curved TIP Syringe
32manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (7), Anhui (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
Showing 12 of 32. All 32 manufacturers in China registered for Syringe, Periodontic, Endodontic, Irrigating
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | EIC |
| Device type | Syringe, Periodontic, Endodontic, Irrigating |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-03-31 |
| Record revised | 2023-02-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60060GCTS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NaviTip Tip | Ultradent Products Inc. | 20 |
| Maxi-probe Irrigation Needle | Tulsa Dental Products LLC | 17 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 14 |
| ACE | Ace Surgical Supply Co., Inc. | 10 |
| Endo-Eze Tip | Ultradent Products Inc. | 10 |
| Kohdent | Kohler Medizintechnik GmbH | 10 |
| Power Dental USA | Power Dental U.S.A. Inc. | 9 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 9 |
| 3D Dental | 3D Dental Designs AND Development, LLC | 8 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 8 |
| CanalPro™ Color Syringes | Coltène/Whaledent AG | 8 |
| CanalPro | Coltene/Whaledent Gmbh & Co. KG | 8 |
Showing 12 of 179. All products under Syringe, Periodontic, Endodontic, Irrigating
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 300 units |
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.