Home GUDID 00850031897038
EvoEndo Model LE Single-Use Gastroscope
Primary DI 00850031897038
Brand EvoEndo Model LE Single-Use Gastroscope
Company Evoendo, Inc.
Model LE
Catalog number 1005
Device description The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of: - Handle - Umbilical Bundle that includes air, water, and suction lines, as well as the video connector - Endoscope shaft with HD Camera
Published 2022-02-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FDS Gastroscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850031897038 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 00850031897038 00850031897038 850031897038 0850031897038
GMDN Terms# Term, Definition table Term Definition Flexible video gastroscope, single-use An endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 1.1 Meter Lumen/Inner Diameter 2 Millimeter Outer Diameter 3.5 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 80 KiloPascal 109 KiloPascal Storage Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 117077970 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850031897076 Single-Use Gastroscope 3.5/2.0 85cm LE 1021 2024-08-30 00850031897083 Single-Use Gastroscope 3.5/2.0 85cm 5-pack LE 1025 2024-08-30 00850031897090 Single-Use Gastroscope 3.5/2.0 85cm DEMO LE 1027 2024-08-30 00850031897014 EvoEndo Model LE Single-Use Gastroscope LE 1001 2022-02-25 00850031897021 EvoEndo Controller EE-C 1002 2022-02-25
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06959664925645 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-06-18 06959664925676 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-06-18 06959664925584 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664925614 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664925959 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664925980 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926017 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926048 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926314 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926345 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926376 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926406 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926673 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926703 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926734 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926765 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927038 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927069 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927090 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927120 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927403 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927434 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927465 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927496 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664928943 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664928974 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664929001 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664929032 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664929070 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664929100 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15