Fiber Optic Light Guide
Siepser shielded fiber optic light probe for identifying debris and fibers in the corneal interface or epithelium. , 20 ga, with Universal connector. Sterile, single-use.
1manufacturer
10catalogue numbers in this listing
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 | Escalon Medical Corp, United States |
|---|---|
| FDA product code | FST |
| Device type | Light, Surgical, Fiberoptic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K875195 |
| Record published | 2016-01-14 |
| Record revised | 2019-07-31 (version 5) |
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 |
| Storage | Storage environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Wide Angle, 20 ga, Universal | In distribution | |
| Wide Angle, 20 ga, TREK/Greishabler | In distribution | |
| 45°Retinal Knife, Universal | In distribution | |
| 45° Retinal Knife, TREK/Greishaber | In distribution | |
| Siepser Shielded | In distribution | |
| Standard, 20 ga, Universal | In distribution | |
| 45°, 20 ga, Universal | In distribution | |
| Standard, 20 ga, TREK/Greishaber | In distribution | |
| 45°, 20 ga, TREK/Greishaber | In distribution | |
| DCR, 20 ga | In distribution |
Same Product Code
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| 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 |
| MI Product Line | Medical Illumination International, Inc | 20 |
| 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 |
Showing 12 of 85. All products under Light, Surgical, Fiberoptic
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.