Caspar Lumbar Specula
Caspar Lumbar Speculum NON-Reflective Black Annodized Coated
3manufacturers in China registered for this device type
6catalogue 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 | 2018-09-20 |
| Record revised | 2026-03-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 45 to 85 mm; width 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 416-826 | Length 75 mm | In distribution |
| 416-823 | 55 x 18 Millimeters | In distribution |
| 416-825 | Width 18 mm | In distribution |
| 416-827 | Width 18 mm | In distribution |
| 416-821 | Length 45 mm | In distribution |
| 416-824 | Width 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 16 |
| Princeton | Princeton Medical Group, Inc. | 9 |
| 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 |
| 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.