Home GUDID 00850031897090
Single-Use Gastroscope 3.5/2.0 85cm DEMO
Primary DI 00850031897090
Brand Single-Use Gastroscope 3.5/2.0 85cm DEMO
Company Evoendo, Inc.
Model LE
Catalog number 1027
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 2024-08-30
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 00850031897090 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 00850031897090 00850031897090 850031897090 0850031897090
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 85 Centimeter Lumen/Inner Diameter 2 Millimeter Outer Diameter 3.5 Millimeter
Regulatory Flags# DUNS number 117077970 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label 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 00850031897014 EvoEndo Model LE Single-Use Gastroscope LE 1001 2022-02-25 00850031897021 EvoEndo Controller EE-C 1002 2022-02-25 00850031897038 EvoEndo Model LE Single-Use Gastroscope LE 1005 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