GEN2
House Suction Irrigator, 2.5 X 4 FR, 95MM
5manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Ningbo Favored Commodity Co., Ltd. | Ningbo | Zhejiang | Specification developer | 21 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| DU-Hope International Group | Nanjing | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | Surgix Medical LLC, United States |
|---|---|
| FDA product code | JZF |
| Device type | Tube, Ear Suction |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-16 |
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 |
| Sizes | Length 70 to 95 mm; catheter gauge 4 to 8 Fr; length 5.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G2E901028 | Length 95 mm | In distribution |
| G2E17055 | Gauge 4 French Gauge (FR) | In distribution |
| G2E17057 | Gauge 5 French Gauge (FR) | In distribution |
| G2E901119 | Length 95 mm | In distribution |
| G2E17050 | In distribution | |
| G2E170510 | Gauge 7 French Gauge (FR) | In distribution |
| G2E170510 | Gauge 7 French Gauge (FR) | In distribution |
| G2E17057 | Gauge 5 French Gauge (FR) | In distribution |
| G2E170514 | Gauge 12 French Gauge (FR) | In distribution |
| G2E17050 | In distribution | |
| G2E901027 | Length 70 mm | In distribution |
| G2E170514 | Gauge 12 French Gauge (FR) | In distribution |
| G2E17055 | Gauge 4 French Gauge (FR) | In distribution |
| G2E901026 | Catheter Gauge 8 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Network | Network Medical Products, Ltd. | 143 |
| MicroFrance® | Integra Microfrance SAS | 137 |
| HNM Medical | HNM Stainless, LLC. | 120 |
| Ambler Surgical | Ambler Surgical, LLC | 101 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 95 |
| Exmoor | Exmoor Plastics Limited | 92 |
| V. Mueller | Steris Corporation | 86 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 78 |
| Integra® | Integra LifeSciences Production Corporation | 77 |
| Bear | Bear-ENT, LLC | 64 |
| Suction Tube | Koros U.S.A., Inc. | 64 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 60 |
Showing 12 of 232. All products under Tube, Ear Suction
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.