EZY Dose
Bulk OTO Scoop BLS
6manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Apothecary Products, LLC., United States |
|---|---|
| FDA product code | JZE |
| Device type | Spoon, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-24 |
| Record revised | 2021-04-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Packaging | Case of 500, inner of 6, case of 24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400928K-A | In distribution | |
| 400928/400928A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Volkmann sharp spoon | Spiggle & Theis Medizintechnik Gmbh | 8 |
| BR Surgical, LLC | BR Surgical LLC | 1 |
| 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.