Novo Surgical
caspar-type bi-valve specula, 45.0 mm blades
3manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Zhejiang (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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | FXE |
| Device type | Speculum, Non-Illuminated |
| 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 |
|---|---|---|
| N6867-58 | In distribution | |
| N6867-59 | In distribution | |
| N6867-57 | In distribution | |
| N6867-61 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 16 |
| Princeton | Princeton Medical Group, Inc. | 9 |
| Caspar Lumbar Specula | Sontec Instruments, Inc. | 6 |
| HNM Medical | HNM Stainless, LLC. | 4 |
| Millennium | Avalign Technologies, Inc. | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 3 |
| Symmetry Brinkerhoff | Aspen Surgical Products, Inc. | 3 |
| Avalign | Avalign Technologies, Inc. | 3 |
| Endocervical Speculum, Ratchet Handle | Gynex Corporation | 2 |
| Ambler Value Line | Ambler Surgical, LLC | 2 |
| Teales Gorget Speculum | Sontec Instruments, Inc. | 2 |
Showing 12 of 15. All products under Speculum, Non-Illuminated
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.