Aesculap
BALFOUR Abdominal Retractor, complete retractor, 7 7/8", (200 mm), depth: 105 mm, width: 250 mm, opening width: 255 mm, consisting of BV616R, non-sterile, reusable, Set
3manufacturers in China registered for this device type
107catalogue 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | FFO |
| Device type | Retractor, Self-Retaining |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-23 |
| Record revised | 2023-08-25 (version 4) |
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 |
| Distribution end date | 2025-12-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BV662R | In distribution | |
| BV551R | In distribution | |
| BV839R | In distribution | |
| BV505R | In distribution | |
| US100202 | In distribution | |
| BV615R | In distribution | |
| BV823R | In distribution | |
| US100201 | In distribution | |
| BV955R | In distribution | |
| BV654R | In distribution | |
| BV580R | In distribution | |
| BV500R | In distribution | |
| BV584R | In distribution | |
| BV815R | In distribution | |
| BV657R | In distribution | |
| RT091R | In distribution | |
| BV842R | In distribution | |
| BV655R | In distribution | |
| BV674R | In distribution | |
| BV502R | In distribution | |
| BV617R | In distribution | |
| BV610R | In distribution | |
| BV670R | In distribution | |
| BV582R | In distribution | |
| BV634R | In distribution | |
| BV608R | In distribution | |
| BV628R | In distribution | |
| BV589R | In distribution | |
| BV680R | In distribution | |
| BV828R | In distribution | |
| BT530R | In distribution | |
| BV962R | In distribution | |
| BV586R | In distribution | |
| BV653R | In distribution | |
| BT529R | In distribution | |
| BT527R | In distribution | |
| BV817R | In distribution | |
| BV952R | In distribution | |
| BT681R | In distribution | |
| BV632R | In distribution | |
| BV650R | In distribution | |
| BV601R | In distribution | |
| BV585R | In distribution | |
| BV676R | In distribution | |
| BV636R | In distribution | |
| BV638R | In distribution | |
| BV660R | In distribution | |
| BV609R | In distribution | |
| BV684R | In distribution | |
| BV826R | In distribution | |
| BV663R | In distribution | |
| BV621R | In distribution | |
| BV649R | In distribution | |
| BV626R | In distribution | |
| BT680R | In distribution | |
| BV512R | In distribution | |
| BV956R | In distribution | |
| BV656R | In distribution | |
| BV645R | In distribution | |
| BV835R | In distribution | |
| BV669R | In distribution | |
| BV829R | In distribution | |
| BV577R | In distribution | |
| BT524R | In distribution | |
| BV906R | In distribution | |
| BV622R | In distribution | |
| BV648R | In distribution | |
| BV583R | In distribution | |
| BV814R | In distribution | |
| BV605R | In distribution | |
| BV646R | In distribution | |
| MA766R | In distribution | |
| BV624R | In distribution | |
| BV682R | In distribution | |
| BV658R | In distribution | |
| BV843R | In distribution | |
| BV819R | In distribution | |
| BV606R | In distribution | |
| BV907R | In distribution | |
| BV647R | In distribution | |
| BV827R | In distribution | |
| BV675R | In distribution | |
| BV840R | In distribution | |
| BV576R | In distribution | |
| BV659R | In distribution | |
| BV091R | In distribution | |
| BV661R | In distribution | |
| BV602R | In distribution | |
| BV957R | In distribution | |
| BV090R | In distribution | |
| BV581R | In distribution | |
| BV575R | In distribution | |
| BV825R | In distribution | |
| BV961R | In distribution | |
| BV954R | In distribution | |
| BV668R | In distribution | |
| BV664R | In distribution | |
| BV672R | In distribution | |
| BV838R | In distribution | |
| BV958R | In distribution | |
| BV665R | In distribution | |
| BV821R | In distribution | |
| BV834R | In distribution | |
| BV578R | In distribution | |
| BV530R | In distribution | |
| BV591R | Withdrawn | |
| MG182R | 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 |
| Mini-Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 105 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 56 |
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.