Home GUDID 05391530810159 EsoFLIP
Primary DI 05391530810159
Brand EsoFLIP
Company CROSPON LIMITED
Model ES-310
Device description EsoFLIP Dilation Catheter for use with EndoFLIP System
Published 2020-04-16
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 true Product Codes# Code, Name table Code Name PIE Esophageal Dilator With Balloon And Electrode Sensors
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PIE Esophageal Dilator With Balloon And Electrode Sensors Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391530810159 Package GS1 5 In Commercial Distribution 05391530810135 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391530810159 05391530810159 5391530810159 05391530810135 05391530810135 5391530810135
GMDN Terms# Term, Definition table Term Definition Gastrointestinal/biliary dilation balloon catheter A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 20 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 989779517 Device count 1 DM exempt false Premarket exempt false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05391530810029 EndoFLIP EF-322 2016-08-02
Other Devices Sharing Product Codes# 
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