MI Product Line
MI-1000 Minor Surgical Light, Floor Stand with Battery Back-up
1manufacturer
20catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Medical Illumination International, Inc, United States |
|---|---|
| FDA product code | FST |
| Device type | Light, Surgical, Fiberoptic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K100388 |
| Record published | 2016-09-23 |
| Record revised | 2024-04-10 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 061525-V | In distribution | |
| 061513-V | In distribution | |
| 061512-V | In distribution | |
| 061513 | In distribution | |
| 061512 | In distribution | |
| 061522 | In distribution | |
| 061523 | In distribution | |
| 061522-V | In distribution | |
| 0615238 | In distribution | |
| 061524 | In distribution | |
| 061513B-V | In distribution | |
| 061524-V | In distribution | |
| 061515 | In distribution | |
| 061523-V | In distribution | |
| 061514 | In distribution | |
| 061514-V | In distribution | |
| 061523B-V | In distribution | |
| 061513B | In distribution | |
| 061525 | In distribution | |
| 061515-V | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System TWO LED | Medical Illumination International, Inc | 109 |
| Vu | Medical Illumination International, Inc | 48 |
| Maxx Luxx LED | Avante | 30 |
| VistOR MS LED | Medical Illumination International, Inc | 21 |
| Vision LED | Avante | 18 |
| Fiberoptic Cable | Black & Black Surgical, Inc. | 17 |
| MaXcess | Nuvasive, Inc. | 17 |
| Integra® | Integra Lifesciences (Ireland) Limited | 16 |
| Integra® | Integra LifeSciences Production Corporation | 14 |
| Snowden-Pencer | Steris Corporation | 11 |
| Vistor PRO LED | Medical Illumination International, Inc | 10 |
| Fiber Optic Light Guide | Escalon Medical Corp | 10 |
Showing 12 of 85. All products under Light, Surgical, Fiberoptic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100388 | 2010-06-22 |
| K053227 | 2006-01-13 |
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.