Novo Surgical Inc.
cottle septum speculum, self-retaining, side adjusting set-screw, narrow tapered blades, 5 1/2" (14.0 cm), blade length: 75.0 mm
9manufacturers in China registered for this device type
87catalogue 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 | 2022-11-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E7210-43 | In distribution | |
| E7473-79 | In distribution | |
| E7210-81 | In distribution | |
| E7210-78 | In distribution | |
| E7210-14 | In distribution | |
| E7210-12 | In distribution | |
| E7813-86 | In distribution | |
| E7210-82 | In distribution | |
| E7210-29 | In distribution | |
| E7210-57 | In distribution | |
| E7714-13 | In distribution | |
| E7210-16 | In distribution | |
| E97473-81 | In distribution | |
| E7210-64 | In distribution | |
| E7210-58 | In distribution | |
| E7210-45E | In distribution | |
| E7210-79 | In distribution | |
| E7210-36E | In distribution | |
| E7210-65 | In distribution | |
| E7813-01 | In distribution | |
| E7210-13 | In distribution | |
| E7210-73 | In distribution | |
| E7210-93E | In distribution | |
| E7210-43.5 | In distribution | |
| E7210-28 | In distribution | |
| E7210-31 | In distribution | |
| E7210-44 | In distribution | |
| E7210-66 | In distribution | |
| E7210-15 | In distribution | |
| E7210-42.5 | In distribution | |
| E7210-43E | In distribution | |
| E7210-77 | In distribution | |
| E7813-81 | In distribution | |
| E7432-93 | In distribution | |
| E7813-41 | In distribution | |
| E97473-76E | In distribution | |
| E7210-84 | In distribution | |
| E7210-42E | In distribution | |
| E7473-78 | In distribution | |
| E7210-67 | In distribution | |
| E7210-46E | In distribution | |
| E7210-80 | In distribution | |
| E7210-35 | In distribution | |
| E7210-22 | In distribution | |
| E97473-76 | In distribution | |
| E7210-32 | In distribution | |
| E7210-18 | In distribution | |
| E7210-24 | In distribution | |
| E7210-42 | In distribution | |
| E7210-60 | In distribution | |
| E7813-66 | In distribution | |
| E7473-76 | In distribution | |
| E7473-76E | In distribution | |
| E7210-74 | In distribution | |
| E7432-92 | In distribution | |
| E7210-21 | In distribution | |
| E7432-94 | In distribution | |
| E7210-33 | In distribution | |
| E7210-11 | In distribution | |
| E7210-86 | In distribution | |
| E7473-55 | In distribution | |
| E7210-20 | In distribution | |
| E7210-76 | In distribution | |
| E7210-91E | In distribution | |
| E7473-77 | In distribution | |
| E7473-53 | In distribution | |
| E7210-68 | In distribution | |
| E7210-93 | In distribution | |
| E7210-70 | In distribution | |
| E7473-54 | In distribution | |
| E7712-22 | In distribution | |
| E7210-44E | In distribution | |
| E7210-91 | In distribution | |
| E7473-46 | In distribution | |
| E7210-46 | In distribution | |
| E7210-23 | In distribution | |
| E7210-56 | In distribution | |
| E7813-46 | In distribution | |
| E7714-14 | In distribution | |
| E7210-85 | In distribution | |
| E7473-81 | In distribution | |
| E7210-35E | In distribution | |
| E7473-52 | In distribution | |
| E7210-61 | In distribution | |
| E7714-12 | In distribution | |
| E7210-45 | In distribution | |
| E7210-62 | 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.