BR Surgical, LLC
BRS Tuning Fork Set, aluminum alloy, complete box set (5 pieces)
11manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Shanghai (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Goldsun Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Wenzhou Kangju Medical Instrument Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 15 |
| ADC Ningbo Co., Ltd. | Ningbo | Zhejiang | Exporter | 13 |
| MDF Instruments Medifriend Inc. | Song Jiang District | Shanghai | Repacker / relabeller | 13 |
| Ningbo Yongjin Medical Instruments Manufacture Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 8 |
| Ningbo Haishu Haoxin Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 6 |
| Taihu Huamei Medical Equipment Co., Ltd. | Anqing | Anhui | Contract manufacturer | 5 |
Record
| Listed by | BR Surgical LLC, United States |
|---|---|
| FDA product code | GWX |
| Device type | Fork, Tuning |
| Device class | Class 1 |
| Regulation | 21 CFR 882.1525 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-24 |
| Record revised | 2023-05-29 (version 2) |
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 |
|---|---|---|
| BR44-06100 | In distribution | |
| BR44-06004 | In distribution | |
| BR44-07002 | In distribution | |
| BR44-07003 | In distribution | |
| BR44-06001 | In distribution | |
| BR44-07004 | In distribution | |
| BR44-07001 | In distribution | |
| BR44-07601 | In distribution | |
| BR44-06002 | In distribution | |
| BR44-06003 | In distribution | |
| BR44-06005 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fentex | Fentex medical GmbH | 22 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 20 |
| Aesculap | Aesculap AG | 15 |
| ADC® | American Diagnostic Corp. | 13 |
| HNM Medical | HNM Stainless, LLC. | 12 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 11 |
| Bear | Bear-ENT, LLC | 10 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Sontec Tuning Fork | Sontec Instruments, Inc. | 7 |
| mytaMed | Mytamed, Inc. | 6 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
| Integra® | Integra LifeSciences Production Corporation | 5 |
Showing 12 of 34. All products under Fork, Tuning
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.