BR Surgical, LLC
Cast Spreader, 3-prong with spring-action, 9"
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (2), Shandong (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 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shengzhou City Sike NEW Materials Technology Co., Ltd. | Shengzhou | Zhejiang | Manufacturer | 1 |
Record
| Listed by | BR Surgical LLC, United States |
|---|---|
| FDA product code | LGG |
| Device type | Instrument, Cast Application/Removal, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5980 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR30-39724 | In distribution | |
| BR30-36623 | In distribution | |
| WG30-36623 | In distribution | |
| FG30-36623 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 32 |
| Sklar® | Sklar Corporation | 22 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 18 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 10 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| Kmedic | Teleflex Medical LLC | 8 |
| Aesculap | Aesculap AG | 7 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 7 |
| Millennium | Avalign Technologies, Inc. | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 6 |
| HNM Medical | HNM Stainless, LLC. | 5 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
Showing 12 of 32. All products under Instrument, Cast Application/Removal, Manual
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.