Gen2
Vienna Nasal Speculum, #2, 30MM Blades, Overall 5.3'' (134MM)
9manufacturers in China registered for this device type
59catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Taizhou Honod Medical Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Surgix Medical LLC, United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-22 |
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 5 to 65 mm; width 5 to 80 mm; length 3.2 to 6.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G2E11045 | Tip Length 8 mm | In distribution |
| G2E901067 | Length 40 mm | In distribution |
| G2E2702 | Length 5.3 in | In distribution |
| G2N994978 | Length 5.75 in | In distribution |
| G2E901022 | Width 80 mm | In distribution |
| G2E2703 | Length 32 mm | In distribution |
| G2E11043 | Tip Length 7 mm | In distribution |
| G2E11043 | Tip Length 7 mm | In distribution |
| G2E901023 | Length 5.75 in | In distribution |
| G2E901069 | Length 40 mm | In distribution |
| G2E11044B | Length 7.8 mm | In distribution |
| G2E901128 | Tip Width 8.0MM | In distribution |
| G2E11038 | Tip Length, 4 mm | In distribution |
| G2E11044 | Tip Length 7.5 mm | In distribution |
| G2E901064 | Length 40 mm | In distribution |
| G2E901277 | In distribution | |
| G2E11040 | Tip Length 5.5 mm | In distribution |
| G2N99497 | Length 6 in | In distribution |
| G2E901281 | In distribution | |
| G2E11038 | Tip Length, 4 mm | In distribution |
| G2E11044 | Tip Length 7.5 mm | In distribution |
| G2E901267 | Length 6.5 in | In distribution |
| G2E901275 | In distribution | |
| G2E11040 | Tip Length 5.5 mm | In distribution |
| G2E901266 | Length 5 mm | In distribution |
| G2E11043B | Length 6 mm | In distribution |
| G2E901278 | In distribution | |
| G2E1280 | Tip Length 25 mm | In distribution |
| G2E901265 | Length 7.5 mm | In distribution |
| G2E901279 | In distribution | |
| G2E11041B | Length 5 mm | In distribution |
| G2O917057 | In distribution | |
| G2E11041 | Tip Length 6 mm | In distribution |
| G2E11039 | Tip Length, 5 mm | In distribution |
| G2O4030 | Length 3.2 in | In distribution |
| G2E901276 | In distribution | |
| G2E11046 | Tip Length 8.5 mm | In distribution |
| G2E11041 | Tip Length 6 mm | In distribution |
| G2E2701 | Length 24 mm | In distribution |
| G2E901282 | In distribution | |
| G2E11039 | Tip Length, 5 mm | In distribution |
| G2E11045 | Tip Length 8 mm | In distribution |
| G2E11045B | Length 7 mm | In distribution |
| G2E11042B | Length 5.5 mm | In distribution |
| G2E11040B | Length 7 mm | In distribution |
| G2N49748 | In distribution | |
| G2N49747 | Length 65 mm | In distribution |
| G2E11042 | Tip Length 6.5 mm | In distribution |
| G2E901127 | Tip Width 3.5MM | In distribution |
| G2E1280 | Tip Length 25 mm | In distribution |
| G2E901183 | In distribution | |
| G2E11042 | Tip Length 6.5 mm | In distribution |
| G2N99358 | Length 5.75 in | In distribution |
| G2E11046 | Tip Length 8.5 mm | In distribution |
| G2E901280 | In distribution | |
| G2E901065 | Length 40 mm | In distribution |
| G2E901066 | Length 40 mm | In distribution |
| G2E901041B | Length 8 mm | In distribution |
| G2E901068 | Length 40 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 203 |
| Ambler Surgical | Ambler Surgical, LLC | 190 |
| Sklar® | Sklar Corporation | 180 |
| Aesculap | Aesculap AG | 170 |
| Boss Instruments | Boss Instruments, Ltd. | 161 |
| Fentex | Fentex medical GmbH | 157 |
| Millennium | Avalign Technologies, Inc. | 148 |
| Bear | Bear-ENT, LLC | 145 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 142 |
| BR Surgical, LLC | BR Surgical LLC | 133 |
| Surtex | Surtex Instruments Ltd | 110 |
| Jedmed | Jedmed Instrument Company | 106 |
Showing 12 of 260. All products under Speculum, Ent
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.