Soltive
TFL Laser Blast Shield
2manufacturers in China registered for this device type
1catalogue number
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 |
| 510(k) | K242191 |
| Record published | 2020-03-23 |
| Record revised | 2025-06-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TFL-ABS | 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 |
| 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 |
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.