Teales Gorget Speculum
Teales Gorget Speculum Tapered Half-Moon Probe End Angled Flat Handle Titanium
3manufacturers in China registered for this device type
2catalogue 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 | Sontec Instruments, 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 | 2025-02-24 |
| Record revised | 2026-05-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Shaft length 4.75 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 516-506 | Handle Length 4 Inch | In distribution |
| T516-507 | Shaft Length 4.75 in | 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 |
| 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 |
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.