FDA.reportPublic FDA data

Open surgical site internal light source

Definition
An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.
GUDID devices
11
Last updated
2021-11-16 00:14:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M678TLC0TRACLUXSUNOPTIC TECHNOLOGIES LLCTLC2021-11-05
00812432022402Orthofix Pro-View Minimal Access Portal SystemLumitex, Inc.70-23042021-09-24
00812432022471June Medical Galaxy II LUX Connect Surgical IlluminatorLumitex, Inc.0125692021-07-23
20885403285353Snowden-PencerCAREFUSION 2200, INC88-1004K2021-03-29
20885403285360Snowden-PencerCAREFUSION 2200, INC88-1005K2021-03-29
20885403285377Snowden-PencerCAREFUSION 2200, INC88-1006K2021-03-29
00812432022426"Thompson Surgical Instruments Flatmat 25"""Lumitex, Inc.0125252021-03-19
00812432022433Thompson Surgical Instruments Small Lightmat 25mmLumitex, Inc.0125112021-03-19
00812432022440Thompson Surgical Instruments Medium Lightmat 50mmLumitex, Inc.0125272021-03-19
00812432022457Thompson Surgical Instruments Large Lightmat 75mmLumitex, Inc.0125292021-03-19
00812432022464LESSpine Innovations Malleable IlluminatorLumitex, Inc.0101042021-03-19