Valve
Valve C-Form Retractor for Oval Frame 12881-22
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
Record
| Listed by | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | FFO |
| Device type | Retractor, Self-Retaining |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-11-16 |
| Record revised | 2025-10-30 (version 2) |
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 | Depth 60 mm; width 16 to 25 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12881-32-000 | Depth 60 mm | In distribution |
| 12881-32-005 | Width 25 mm | In distribution |
| 12881-32-001 | Width 16 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 1,870 |
| Omni-Tract® | Integra Lifesciences Corporation | 347 |
| Mediflex Universal Round Bar Table Mounted Retractor Systems | Flexbar Machine Corp. | 271 |
| Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 209 |
| Sklar® | Sklar Corporation | 203 |
| Pilling | Teleflex Medical LLC | 184 |
| Hayden Medical | Hayden Medical Inc | 172 |
| V. Mueller | Steris Corporation | 158 |
| Ambler Surgical | Ambler Surgical, LLC | 118 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 115 |
| Aesculap | Aesculap AG | 107 |
| Mini-Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 105 |
Showing 12 of 178. All products under Retractor, Self-Retaining
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.