V. Mueller
Shambaugh Irrigator Fingertip Control Curved Overall Length 6-1/8" (15.6CM)
27manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (6), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Hebei Youjie Medical Devices Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 18 |
| Dongguan Yipincheng Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 17 |
Showing 12 of 27. All 27 manufacturers in China registered for Irrigator, Sinus
Record
| Listed by | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | KAR |
| Device type | Irrigator, Sinus |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-13 |
| Record revised | 2019-03-28 (version 2) |
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 |
| Distribution end date | 2018-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AU11390 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aesculap | Aesculap AG | 20 |
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| Avalign | Avalign Technologies, Inc. | 15 |
| Boss Instruments | Boss Instruments, Ltd. | 12 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
| Pilling | Teleflex Medical LLC | 10 |
| AED | National Advanced Endoscopy Devices, Inc. | 5 |
| GEN2 | Surgix Medical LLC | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| Millennium | Avalign Technologies, Inc. | 4 |
| InhwRior | Shenzhen Yuechuan Trade Co., Ltd. | 4 |
| Cannula | KLS-Martin L.P. | 3 |
Showing 12 of 24. All products under Irrigator, Sinus
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.