Home GUDID 00860003252598 Lumicell Direct Visualization System (DVS)
Primary DI 00860003252598
Brand Lumicell Direct Visualization System (DVS)
Company Lumicell, Inc.
Model 810-00212
Device description Light source
Published 2024-11-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name SAW Fluorescence Imaging For Breast Cancer Detection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SAW Fluorescence Imaging For Breast Cancer Detection Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860003252598 Package GS1 1 In Commercial Distribution 00860003252536 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860003252598 00860003252598 860003252598 0860003252598 00860003252536 00860003252536 860003252536 0860003252536
GMDN Terms# Term, Definition table Term Definition Intraoperative tumour margin fluorescence imaging system An electrically-powered fluorescence imaging device assembly intended to be used during surgery for the excitation of an injected fluorophore (e.g., pegulicianine) to enable intraoperative detection of residual cancerous tissue in the resection cavity following removal of the primary specimen during a surgical procedure (e.g., lumpectomy). It is a software-operated system typically consisting of a computer with a display and controls, a light source and handheld excitation probe with a camera for image capture. It is designed to illuminate residual cancerous tissue to facilitate image-guided surgery.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 41 Degrees Fahrenheit 82.4 Degrees Fahrenheit Storage Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 41 Degrees Fahrenheit 122 Degrees Fahrenheit
Regulatory Flags# DUNS number 832329788 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true Lot or batch true Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860003252505 Lumicell Direct Visualization System (DVS) 810-00210 2024-11-19 00860003252536 Lumicell Direct Visualization System (DVS) 810-00212 2024-11-19 00860003252567 Lumicell Direct Visualization System (DVS) 810-00214 2024-11-19 00860003252512 Lumicell Direct Visualization System (DVS) 810-00210 2024-11-19 00860003252543 Lumicell Direct Visualization System (DVS) 810-00217 2024-11-19 00860003252550 Lumicell Direct Visualization System (DVS) 810-00211 810-00211 2024-11-19 00860008537829 Lumicell Direct Visualization System (DVS) 810-00214 2024-11-19 00860008537898 Lumicell Direct Visualization System (DVS) 900-00209 2024-11-19
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860003252505 Lumicell Direct Visualization System (DVS) Lumicell, Inc. SAW 2024-11-19 00860003252536 Lumicell Direct Visualization System (DVS) Lumicell, Inc. SAW 2024-11-19 00860003252567 Lumicell Direct Visualization System (DVS) Lumicell, Inc. SAW 2024-11-19 00860003252512 Lumicell Direct Visualization System (DVS) Lumicell, Inc. SAW 2024-11-19 00860003252543 Lumicell Direct Visualization System (DVS) Lumicell, Inc. SAW 2024-11-19 00860003252550 Lumicell Direct Visualization System (DVS) Lumicell, Inc. SAW 2024-11-19 00860008537829 Lumicell Direct Visualization System (DVS) Lumicell, Inc. SAW 2024-11-19 00860008537898 Lumicell Direct Visualization System (DVS) Lumicell, Inc. SAW 2024-11-19
lumicell.com