Gsource
gWire Passer/Retriever Fcps 6", w/drill guide, OD 3.0mm, max cap 1.5mm [17 gauge] wire
6manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Qingdao Zhixing Medical Instrument Co., Ltd. | Qingdao | Shandong | Manufacturer | 6 |
| Dongguan Senmed Medical Instrument Co., Ltd. | Dongguar | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | HWQ |
| Device type | Passer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-02 |
| Record revised | 2022-08-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| gS 82.4962 | In distribution | |
| gS 82.4964 | In distribution | |
| gS 82.4941 | In distribution | |
| gS 82.4960 | In distribution | |
| gS 82.4942 | In distribution | |
| gS 82.4970 | In distribution | |
| gS 82.4930 | In distribution | |
| gS 82.4940 | In distribution | |
| gS 82.4966 | In distribution | |
| gS 82.4870 | In distribution | |
| gS 82.4890 | In distribution | |
| gS 82.4918 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex | Provision | 76 |
| Medline | Medline Industries, Inc. | 32 |
| Conmed/Linvatec | Provision | 24 |
| Stryker | Provision | 22 |
| Cylox ST | Signus Medizintechnik Gmbh | 16 |
| Apex | Stryker GmbH | 16 |
| EZ Pass | Biomet Orthopedics | 14 |
| Passer | Smith & Nephew, Inc. | 13 |
| Millennium | Avalign Technologies, Inc. | 11 |
| Medline Renewal | Medline Industries, Inc. | 9 |
| EZPass™ | Biomet Orthopedics | 7 |
| Speedpass Disposable | Biomet Orthopedics | 7 |
Showing 12 of 130. All products under Passer
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.