Hydrodebrider®
Hydrodebrider 1914001 STD Handpiece Rohs
63manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (37), Zhejiang (10), Jiangsu (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Cotronic Technology Limited | Shenzhen, Guang Dong | Guangdong | Contract manufacturer | 5 |
| Shantou City KIN Seng Plastic Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
Showing 12 of 63. All 63 manufacturers in China registered for Irrigator, Powered Nasal
Record
| Listed by | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | KMA |
| Device type | Irrigator, Powered Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5550 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-10-16 |
| Record revised | 2018-03-29 (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, serial number |
| Storage | Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1913001 | In distribution | |
| 1913001 | In distribution | |
| 1914001 | In distribution | |
| 1914001 | In distribution | |
| 1914001 | In distribution | |
| 1921002 | In distribution | |
| 1921002 | In distribution | |
| 1913001 | In distribution | |
| 1913001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SinuPulse | Health Solutions Medical Products, Corp. | 4 |
| iHealth | iHealth Labs, Inc. | 3 |
| Naväge | Rhinosystems, Inc. | 3 |
| Berrcom | Guangzhou Berrcom Medical Device Co., Ltd. | 3 |
| InhwRior | Shenzhen Yuechuan Trade Co., Ltd. | 2 |
| Braun | KAZ USA, Inc. | 2 |
| HealthSmart | D-M-S Holdings, Inc. | 2 |
| Bios Diagnostics | Thermor Ltd. | 2 |
| Cleaning sheath for Ø3.1mm X 170mm 45° R | Henke-Sass Wolf, Gmbh. | 1 |
| Cleaning sheath for Ø3.1mm X 170mm 0° | Henke-Sass Wolf, Gmbh. | 1 |
| Cleaning sheath for Ø4mm X 155mm 45° | Henke-Sass Wolf, Gmbh. | 1 |
| Breathe Comfort | Slv Pharmaceuticals LLC | 1 |
Showing 12 of 36. All products under Irrigator, Powered Nasal
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.