USA Elite
USA Elite System Cysto-Resectoscope Spacer Use With USA Elite System Short Bridge, Rigid Forceps And Resectoscope Sheaths
2manufacturers in China registered for this device type
2catalogue 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 | 2016-10-14 |
| Record revised | 2024-09-02 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESCR | In distribution | |
| E8217 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gyrus Acmi | Gyrus Acmi, Inc. | 41 |
| 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 |
| 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.