Home GUDID 00893029002199 Spot Ex CE Endoscopic Tattoo
Primary DI 00893029002199
Brand Spot Ex CE Endoscopic Tattoo
Company GI Supply, Inc.
Model GIS-46
Catalog number GIS-46S
Device description Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up to 36 months to facilitate clinical surveillance or surgical localization.
Published 2021-07-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name NGB Test, Glycosylated Hemoglobin, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NGB Test, Glycosylated Hemoglobin, Over The Counter Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10893029002196 Package GS1 10 In Commercial Distribution 00893029002199 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 10893029002196 10893029002196 00893029002199 00893029002199 893029002199 0893029002199
GMDN Terms# Term, Definition table Term Definition Tissue marking ink A sterile liquid substance intended to be injected into tissue to identify lesions; it is also used externally on the skin to mark incision sites. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 0 Degrees Celsius
Regulatory Flags# DUNS number 160990313 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10893029002196 Spot Ex CE Endoscopic Tattoo GI Supply, Inc. NGB 2021-07-07
gi-supply.com