Ambler Surgical
Schuknecht ''Whirlybird'' excavator, 6 3/8'', angled shaft, slightly curved, offset to the right, small, 0.75mm wide blade, round handle
6manufacturers in China registered for this device type
23catalogue 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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | JYH |
| Device type | Excavator, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
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 |
|---|---|---|
| Schuknecht ”Whirlybird” excavator | In distribution | |
| Austin attic dissector | In distribution | |
| Curette excavator | In distribution | |
| Hough oval window excavator | In distribution | |
| Hough stapedial footplate auger | In distribution | |
| Curette excavator | In distribution | |
| Curette excavator | In distribution | |
| Hough stapedial footplate auger | In distribution | |
| Hough oval window excavator | In distribution | |
| Curette excavator | In distribution | |
| Hough extractor | In distribution | |
| Hough extractor | In distribution | |
| House-Hough excavator | In distribution | |
| Hough drum scraper | In distribution | |
| Curette excavator | In distribution | |
| Curette excavator | In distribution | |
| Curette excavator | In distribution | |
| Schuknecht ”Whirlybird” excavator | In distribution | |
| Austin excavator | In distribution | |
| Curette excavator | In distribution | |
| Curette excavator | In distribution | |
| Curette excavator | In distribution | |
| Austin excavator | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.