Gyrus Acmi
Surlok Stone Grasping Forceps Nonretracting 3.0 FR (1.0 mm) X 120 cm basket Width: 16 mm # of Wires: 3
2manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Innovex Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | FGO |
| Device type | Dislodger, Stone, Flexible |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4680 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-03 |
| Record revised | 2024-09-02 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5700004 | In distribution | |
| 5710002 | In distribution | |
| 5700015 | In distribution | |
| 5700011 | In distribution | |
| 5720009 | In distribution | |
| 5700009 | In distribution | |
| 5711012 | In distribution | |
| 5700008 | In distribution | |
| 5710009 | In distribution | |
| 5710008 | In distribution | |
| 5700017 | In distribution | |
| 5720010 | In distribution | |
| 5720000 | In distribution | |
| 5711008 | In distribution | |
| 5720006 | In distribution | |
| 5711004 | In distribution | |
| 5710001 | In distribution | |
| 5710006 | In distribution | |
| 5710003 | In distribution | |
| 5720005 | In distribution | |
| 5700006 | In distribution | |
| 5720003 | In distribution | |
| RAG-337R | In distribution | |
| 5700001 | In distribution | |
| 5700014 | In distribution | |
| 5710004 | In distribution | |
| 5720004 | In distribution | |
| 5720002 | In distribution | |
| 5710005 | In distribution | |
| 5720008 | In distribution | |
| 5700010 | In distribution | |
| 5720001 | In distribution | |
| 5700002 | In distribution | |
| 5710011 | In distribution | |
| 5700005 | In distribution | |
| 5711002 | In distribution | |
| 5710007 | In distribution | |
| 5700016 | In distribution | |
| 5720007 | In distribution | |
| 5710000 | In distribution | |
| 5710010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dornier MedTech | Dornier Medtech America, Inc. | 13 |
| Olympus | Gyrus Acmi, Inc. | 7 |
| Dislodger, Stone, Flexible | Stryker GmbH | 5 |
| Falcon | Us Endoscopy | 2 |
| Talon | Us Endoscopy | 2 |
| USA Elite | Gyrus Acmi, Inc. | 2 |
| Stone Cone | Boston Scientific Corporation | 2 |
| Gyrus Icmi | Gyrus Acmi, Inc. | 1 |
| Stone Retrieval Basket | Applied Medical Resources Corp. | 1 |
| Soltive | Gyrus Acmi, Inc. | 1 |
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.