Home GUDID 20816908010690 OnLite
Primary DI 20816908010690
Brand OnLite
Company CYALUME TECHNOLOGIES, INC.
Model 7-1028B
Catalog number 7-1028B
Device description Vaginal Illuminator (Blue)
Published 2017-04-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MPU Source, Chemiluminescent Light
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MPU Source, Chemiluminescent Light Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10816908010693 Package GS1 25 In Commercial Distribution 20816908010690 Package GS1 10 In Commercial Distribution 00816908010696 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 10816908010693 10816908010693 20816908010690 20816908010690 00816908010696 00816908010696 816908010696 0816908010696
GMDN Terms# Term, Definition table Term Definition Vaginal illuminator A device used to illuminate the vagina during a gynaecological examination or procedure. It is typically a chemiluminescent illumination source that is attached to the upper dilator blade of a vaginal speculum. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 40 Degrees Fahrenheit 90 Degrees Fahrenheit
Regulatory Flags# DUNS number 154779748 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
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