CSU Balfour Retractor
CSU Balfour Retractor Double BAR With Extra Large Blades
3manufacturers in China registered for this device type
4catalogue 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 | 2019-06-18 |
| Record revised | 2019-11-26 (version 3) |
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 4 to 7.5 in |
| Distribution end date | 2019-11-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1100-610 | Length 7.5 in | In distribution |
| 1100-613Q | 6 Inch Blade Spread | In distribution |
| 1100-611 | Length 4 in | Withdrawn |
| 1100-611C | Length 7 in | Withdrawn |
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.