Ambler Surgical
Barr self-retaining anal retractor, 8'', 2 3/4'' deep x 7/8'' wide blades, ring handle with ratchet catch
3manufacturers in China registered for this device type
16catalogue 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 | Ambler Surgical, LLC, 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 | 2021-01-04 |
| Record revised | 2023-11-17 (version 2) |
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 |
|---|---|---|
| Hirschman rectal anoscope speculum | In distribution | |
| Brinkerhoff rectal speculum | In distribution | |
| Fansler proctoscope | In distribution | |
| Sims rectal speculum | In distribution | |
| Chelsea-Eaton anal speculum | In distribution | |
| Brinkerhoff rectal speculum | In distribution | |
| Barr self-retaining anal retractor | In distribution | |
| Sims rectal speculum | In distribution | |
| Brinkerhoff rectal speculum | In distribution | |
| Chelsea-Eaton anal speculum | In distribution | |
| Hirschman rectal anoscope speculum | In distribution | |
| Sims rectal speculum | In distribution | |
| Fansler-Ives rectal speculum | In distribution | |
| Sims rectal speculum | In distribution | |
| Sims rectal speculum | In distribution | |
| Hirschman rectal anoscope speculum | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.