PremierPro
Ear & Ulcer Syringe, 3oz, DEHP Free, Sterile
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| Ucomfor Medical Co., Ltd. | Shanghai | Shanghai | Exporter | 17 |
Record
| Listed by | Prestige Ameritech, United States |
|---|---|
| FDA product code | JYH |
| Device type | Excavator, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-04 |
| Record revised | 2026-03-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3611 | In distribution | |
| 3610 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 23 |
| HNM Medical | HNM Stainless, LLC. | 12 |
| Boss Instruments | Boss Instruments, Ltd. | 11 |
| Aesculap | Aesculap AG | 10 |
| V. Mueller | Steris Corporation | 9 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 8 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 7 |
| Avalign | Avalign Technologies, Inc. | 7 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 7 |
| Pilling | Teleflex Medical LLC | 7 |
| Millennium | Avalign Technologies, Inc. | 6 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
Showing 12 of 33. All products under Excavator, Ear
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.