Novo Surgical
zenith sims vaginal retractor, double-ended, flat handle, size 3, blades 1-1/2" x 3-1/4" deep (3.8 cm x 8.3 cm) & x 1-5/8" x 3-1/2" (4.1 cm x 8.9 cm), 7-1/8" (18.0 cm)
8manufacturers in China registered for this device type
52catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| 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 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | HDL |
| Device type | Retractor, Vaginal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| 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 |
|---|---|---|
| OB96338-64 | In distribution | |
| OB96337-34 | In distribution | |
| OB96337-12 | In distribution | |
| OB96334-42 | In distribution | |
| OB96338-63 | In distribution | |
| OB6331-31 | In distribution | |
| OB6336-32 | In distribution | |
| OB6334-42 | In distribution | |
| OB96338-38 | In distribution | |
| OB96337-81 | In distribution | |
| OB96334-12 | In distribution | |
| OB6335-32 | In distribution | |
| OB6335-12 | In distribution | |
| OB6335-31 | In distribution | |
| OB6336-12 | In distribution | |
| OB6417-31 | In distribution | |
| OB96334-44 | In distribution | |
| OB6336-13 | In distribution | |
| OB96337-43 | In distribution | |
| OB96331-12 | In distribution | |
| OB6335-14 | In distribution | |
| OB6318-95 | In distribution | |
| OB96334-43 | In distribution | |
| OB6335-11 | In distribution | |
| OB96337-82 | In distribution | |
| OB6336-34 | In distribution | |
| OB96331-13 | In distribution | |
| OB6335-34 | In distribution | |
| OB6336-11 | In distribution | |
| OB6336-33 | In distribution | |
| OB6326-27 | In distribution | |
| OB96331-14 | In distribution | |
| OB96337-45 | In distribution | |
| OB96338-62 | In distribution | |
| OB96331-31 | In distribution | |
| OB6338-38E | In distribution | |
| OB6318-94 | In distribution | |
| OB6338-38NC | In distribution | |
| OB96334-14 | In distribution | |
| OB6335-13 | In distribution | |
| OB96337-14 | In distribution | |
| OB6337-43 | In distribution | |
| OB96334-51 | In distribution | |
| OB96337-16 | In distribution | |
| OB96337-13 | In distribution | |
| OB96337-55 | In distribution | |
| OB96334-13 | In distribution | |
| OB96337-15 | In distribution | |
| OB96337-65 | In distribution | |
| OB6335-33 | In distribution | |
| OB6336-14 | In distribution | |
| OB96337-75 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 72 |
| Ambler Surgical | Ambler Surgical, LLC | 60 |
| HNM Medical | HNM Stainless, LLC. | 52 |
| Elmed Incorporated | Elmed, Inc. | 48 |
| Millennium | Avalign Technologies, Inc. | 47 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 43 |
| Aesculap | Aesculap AG | 38 |
| Surgical Direct | Surgical Direct, Inc. | 27 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 25 |
| Pilling | Teleflex Medical LLC | 25 |
| V. Mueller | Steris Corporation | 22 |
| Boss Instruments | Boss Instruments, Ltd. | 22 |
Showing 12 of 59. All products under Retractor, Vaginal
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.