BR Surgical, LLC
GROSS Ear Spoon & Hook, 4 3/4"
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dalian Wenjing Wooden Industry Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 6 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Amis (Xiamen) Cultural Creativity Co., Ltd. | Xiamen | Fujian | Manufacturer | 28 |
| Vastrade Manufacturing Corporation | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen Joose Beauty Electronic Co., Ltd. | Shen Zhen | Guangdong | Contract manufacturer | 13 |
| Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd. | Jintan | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | BR Surgical LLC, United States |
|---|---|
| FDA product code | JZE |
| Device type | Spoon, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-21 |
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 |
|---|---|---|
| BR44-17112 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Volkmann sharp spoon | Spiggle & Theis Medizintechnik Gmbh | 8 |
| EZY Dose | Apothecary Products, LLC. | 2 |
| Marina Medical | Marina Medical Instruments, Inc. | 1 |
| Equate | Wal Mart Stores, Inc | 1 |
| Walgreens | Walgreen Co. | 1 |
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.