Novo Surgical
zenith cottle septum speculum, self-retaining, side adjusting set-screw, narrow tapered blades, 5-1/2" (14.0 cm), blade length: 35.0 mm
9manufacturers in China registered for this device type
103catalogue 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 | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-12-18 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E97813-46 | In distribution | |
| E97210-91 | In distribution | |
| E97210-73 | In distribution | |
| E7210-55 | In distribution | |
| E7312-54 | In distribution | |
| E7210-47E | In distribution | |
| E7210-44.5E | In distribution | |
| E7210-51 | In distribution | |
| E7473-77L | In distribution | |
| E7210-41E | In distribution | |
| E97210-41 | In distribution | |
| E7473-78R | In distribution | |
| E97210-30 | In distribution | |
| E7210-40 | In distribution | |
| E97210-58 | In distribution | |
| E7210-25 | In distribution | |
| E7432-95 | In distribution | |
| E97210-82 | In distribution | |
| E97210-51 | In distribution | |
| E7473-78L | In distribution | |
| E97210-93 | In distribution | |
| E97210-68 | In distribution | |
| E97210-72 | In distribution | |
| E7210-44.5 | In distribution | |
| E97210-70 | In distribution | |
| E97210-31 | In distribution | |
| E97210-33 | In distribution | |
| E97714-14 | In distribution | |
| E7473-77R | In distribution | |
| E7210-38 | In distribution | |
| E97210-47 | In distribution | |
| E97210-65 | In distribution | |
| E7210-30 | In distribution | |
| E7210-27 | In distribution | |
| E7210-48E | In distribution | |
| E7210-69 | In distribution | |
| E7210-47 | In distribution | |
| E97210-85 | In distribution | |
| E7210-52 | In distribution | |
| E7210-34 | In distribution | |
| E97210-67 | In distribution | |
| E97210-38 | In distribution | |
| E97210-69 | In distribution | |
| E7210-39 | In distribution | |
| E97210-34 | In distribution | |
| E97210-74 | In distribution | |
| E7210-37 | In distribution | |
| E7210-72 | In distribution | |
| E97210-36 | In distribution | |
| E7210-19 | In distribution | |
| E7210-95 | In distribution | |
| E7210-71 | In distribution | |
| E97710-12 | In distribution | |
| E97714-13 | In distribution | |
| E97210-44.5 | In distribution | |
| E97210-64 | In distribution | |
| E7210-45.5 | In distribution | |
| E97813-66 | In distribution | |
| E7210-36 | In distribution | |
| E97210-60 | In distribution | |
| E97710-13 | In distribution | |
| E7210-59 | In distribution | |
| E7210-50 | In distribution | |
| E97714-12 | In distribution | |
| E97210-43.5 | In distribution | |
| E97210-13 | In distribution | |
| E7210-42.5E | In distribution | |
| E97210-71 | In distribution | |
| E7210-37E | In distribution | |
| E97210-42 | In distribution | |
| E7210-48 | In distribution | |
| E97813-01 | In distribution | |
| E97210-44 | In distribution | |
| E97210-32 | In distribution | |
| E97210-16 | In distribution | |
| E97813-81 | In distribution | |
| E97210-46 | In distribution | |
| E97210-42.5 | In distribution | |
| E97210-12 | In distribution | |
| E97210-39 | In distribution | |
| E97710-14 | In distribution | |
| E7210-41 | In distribution | |
| E7210-10 | In distribution | |
| E97210-20 | In distribution | |
| E97210-48 | In distribution | |
| E7210-45.5E | In distribution | |
| E7210-30E | In distribution | |
| E97210-15 | In distribution | |
| E7210-39E | In distribution | |
| E97813-86 | In distribution | |
| E7210-26 | In distribution | |
| E97210-62 | In distribution | |
| E97210-29 | In distribution | |
| E7312-53 | In distribution | |
| E97210-80 | In distribution | |
| E97210-86 | In distribution | |
| E7210-17 | In distribution | |
| E7210-38E | In distribution | |
| E97210-37 | In distribution | |
| E97210-66 | In distribution | |
| E97210-35 | In distribution | |
| E97210-40 | In distribution | |
| E7210-43.5E | 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.