Home GUDID 00816908010696 OnLite
Primary DI 00816908010696
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 Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 Not in Commercial Distribution 20816908010690 Package GS1 10 Not 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 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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