Evonos
Austin Dissection Knife 90 Degree Blade Angle 1.02 MM Blade Length Stainless Steel Ebony
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Jiangsu Yongle Medical Technology Co., Ltd. | Taixing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | LRC |
| Device type | Instrument, Ent Manual Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-10 |
| Record revised | 2024-09-02 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130362 | In distribution | |
| 230077 | In distribution | |
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Showing 250 of 291 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Ent Manual Surgical | Karl Storz GmbH & Co. KG | 2,062 |
| Fentex | Fentex medical GmbH | 1,738 |
| Elmed | Elmed, Inc. | 504 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 441 |
| Millennium | Avalign Technologies, Inc. | 283 |
| Elmed Incorporated | Elmed, Inc. | 277 |
| Instrument, Ent Manual Surgical | Stryker Leibinger Gmbh & Co. KG | 169 |
| Rhinoforce | Karl Storz GmbH & Co. KG | 112 |
| Surtex | Surtex Instruments Ltd | 85 |
| Kerrison sphenoid punch | Spiggle & Theis Medizintechnik Gmbh | 82 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 78 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 63 |
Showing 12 of 661. All products under Instrument, Ent Manual Surgical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-05-24 | Class II | Employee error | lack of sterility assurance | 100 boxes of 6 units | 2014-05-30 |
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.