UltraLite®
Integra® UltraLite® Pro headlight with 9 ft. premium bifurcated cable, Headlight Module and Gownclips
1manufacturer
5catalogue 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 | Integra Lifesciences (Ireland) Limited, Ireland |
|---|---|
| FDA product code | FST |
| Device type | Light, Surgical, Fiberoptic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K864380 |
| Record published | 2016-08-31 |
| Record revised | 2023-05-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 001370LX | In distribution | |
| AX1385BIF | In distribution | |
| AX1375BIF | In distribution | |
| 001387LX | In distribution | |
| AX2100BIF | 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 |
| 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
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2011-10-10 | Not classified | Device Design | Headlight assembly (module) may become loose and separate from the headband assembly | 2181 units | 2012-10-01 |
| Integra Lifesciences Corporation | 510(k) number | 2011-10-10 | Not classified | Device Design | Headlight assembly (module) may become loose and separate from the headband assembly | 965 units | 2012-10-01 |
| Integra Lifesciences Corporation | 510(k) number | 2011-10-10 | Not classified | Device Design | Headlight assembly (module) may become loose and separate from the headband assembly | 2800 units | 2012-10-01 |
| Integra Lifesciences Corporation | 510(k) number | 2011-10-10 | Not classified | Device Design | Headlight assembly (module) may become loose and separate from the headband assembly | 198 units | 2012-10-01 |
| Integra Lifesciences Corporation | 510(k) number | 2011-10-10 | Not classified | Device Design | Headlight assembly (module) may become loose and separate from the headband assembly | 762 units | 2012-10-01 |
| Integra Lifesciences Corporation | 510(k) number | 2011-10-10 | Not classified | Device Design | Headlight assembly (module) may become loose and separate from the headband assembly | 90 units | 2012-10-01 |
| Integra Lifesciences Corporation | 510(k) number | 2011-10-10 | Not classified | Device Design | Headlight assembly (module) may become loose and separate from the headband assembly | 1 unit | 2012-10-01 |
| Integra Lifesciences Corporation | 510(k) number | 2011-10-10 | Not classified | Device Design | Headlight assembly (module) may become loose and separate from the headband assembly | 60 units | 2012-10-01 |
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.