Novo Surgical Inc.
hardy bi-valve specula, 13.0 mm x 70.0 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 | 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 |
|---|---|---|
| N6846-66 | In distribution | |
| N6846-68 | In distribution | |
| N6846-67 | In distribution | |
| N6867-50 | 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 | 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.