Home GUDID 10893029002196 Spot Ex CE Endoscopic Tattoo
Primary DI 10893029002196
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
Rx false
OTC false
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 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 true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00893029002199 Spot Ex CE Endoscopic Tattoo GI Supply, Inc. NGB 2021-07-07
gi-supply.com