Gyrus Acmi
Disposable Rains Sinus Irrigation Cannula, Malleable Shaft Working Length: 4.25" (108MM) Diameter: 6 French
11manufacturers in China registered for this device type
78catalogue numbers in this listing
1recall
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 | 2024-10-18 (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 |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 6, pack of 12 |
| Distribution end date | 2026-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70130928 | In distribution | |
| 130718 | In distribution | |
| 70134011 | In distribution | |
| 130438 | In distribution | |
| 70130929 | In distribution | |
| 130783 | In distribution | |
| 131401 | In distribution | |
| 130725 | In distribution | |
| 130787 | In distribution | |
| 550535 | In distribution | |
| 130044 | In distribution | |
| 130915 | In distribution | |
| 70131350 | In distribution | |
| 130726 | In distribution | |
| 70131352 | In distribution | |
| 130751 | In distribution | |
| 70325512 | In distribution | |
| 70130925 | In distribution | |
| 130255 | In distribution | |
| 70130931 | In distribution | |
| 70130717 | In distribution | |
| 130062 | In distribution | |
| 130128 | In distribution | |
| 130785 | In distribution | |
| 70890207 | In distribution | |
| 130563 | In distribution | |
| 130355 | In distribution | |
| 130750 | In distribution | |
| 130710 | In distribution | |
| 70130794 | In distribution | |
| 70131323 | In distribution | |
| 70131322 | In distribution | |
| 130916 | In distribution | |
| 130047 | In distribution | |
| 130811 | In distribution | |
| 130720 | In distribution | |
| 70230050 | In distribution | |
| 130448 | In distribution | |
| 70130791 | In distribution | |
| 70130790 | In distribution | |
| 130755 | In distribution | |
| 70130780 | In distribution | |
| 130045 | In distribution | |
| 130752 | In distribution | |
| 70130926 | In distribution | |
| 70130781 | In distribution | |
| 130724 | In distribution | |
| 130722 | In distribution | |
| 70130930 | In distribution | |
| 70131356 | In distribution | |
| 325508 | In distribution | |
| 130789 | In distribution | |
| 70130933 | In distribution | |
| 70130927 | In distribution | |
| 70131321 | In distribution | |
| 130042 | In distribution | |
| 130562 | In distribution | |
| 70131354 | In distribution | |
| 890205 | In distribution | |
| 130762 | Withdrawn | |
| 231002 | Withdrawn | |
| 130759 | Withdrawn | |
| 70131011 | Withdrawn | |
| 130028 | Withdrawn | |
| 270210 | Withdrawn | |
| 70130792 | Withdrawn | |
| 130303 | Withdrawn | |
| 130761 | Withdrawn | |
| 551000 | Withdrawn | |
| 231014 | Withdrawn | |
| 130443 | Withdrawn | |
| 130760 | Withdrawn | |
| 917605 | Withdrawn | |
| 70130793 | Withdrawn | |
| 130025-ENT | Withdrawn | |
| 130756 | Withdrawn | |
| 130082 | Withdrawn | |
| 230064 | Withdrawn |
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 |
| Evonos | Gyrus Acmi, Inc. | 291 |
| 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 |
| 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.