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Fiber Optic Light Cable
GULF FIBEROPTICS, INC. · Model 4.6mm bundle diameter, 9.9' length, Bifurcated Cable · UDI-DI 00857580006744
FDG
Prescription
2
510(k) clearances
89
Adverse events
2
Recalls
76
Facilities
Description
A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-07-01 | Lumitex Inc | Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifi |
| 2008-10-24 | Biomet Microfixation, Inc. | Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.