Mi-Eye 3
mi-eye 3 is a rigid needlescope used to illuminate and view an internal body cavity during arthroscopic or endoscopic procedures. A camera, imaging optics and LED illumination sit at the…
mi-eye 3 is a rigid needlescope used to illuminate and view an internal body cavity during arthroscopic or endoscopic procedures. A camera, imaging optics and LED illumination sit at the probe tip, and a cable connects the probe to the reusable mi-tablet 3 display.
The sterile probe is intended for single use and receives power from the tablet. The monitor displays real-time images on a 12-inch screen. The with-cannula configuration provides instruments for creating and maintaining an access channel to the viewing site.
Listed Item
mi-eye 3 25 deg scope, 75mm with cannula
Access and Irrigation
The with-cannula probe is packaged with a scalpel, cannula, obturator and switching stick. Irrigation can pass through the distal end of the probe from a solution supplied by the user at the handle. This keeps visualization and irrigation functions in the same probe path.
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 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 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | Trice Medical, United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K212556 |
| Record published | 2022-12-09 |
| Record revised | 2023-11-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T300-095C | In distribution | |
| T315-120 | In distribution | |
| T300-160 | In distribution | |
| T325-095C | In distribution | |
| T325-075C | In distribution | |
| T300-095 | In distribution | |
| T300-075C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212556 | 2021-09-15 |
| K162475 | 2016-09-16 |
| K141119 | 2014-07-29 |
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.