Boss Instruments
Oval Window Excavator, right, hvy hndl and shft TW 0.8mm
6manufacturers in China registered for this device type
11catalogue 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 | Boss Instruments, Ltd., United States |
|---|---|
| FDA product code | JYH |
| Device type | Excavator, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90-3213 | In distribution | |
| 90-3214 | In distribution | |
| 90-3330 | In distribution | |
| 90-3564 | In distribution | |
| 90-3006 | In distribution | |
| 90-3212 | In distribution | |
| 90-3708 | In distribution | |
| 90-3707 | In distribution | |
| 90-3911 | In distribution | |
| 90-3211 | In distribution | |
| 90-3005 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 23 |
| HNM Medical | HNM Stainless, LLC. | 12 |
| 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 |
| GEN2 | Surgix Medical LLC | 4 |
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.