Single-Use Gastroscope 3.5/2.0 85cm 1021

GUDID 00850031897076

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

Evoendo, Inc.

Flexible video gastroscope, single-use

• Primary Device ID: 00850031897076
• NIH Device Record Key: 788fbd65-7b9a-41b7-978f-f9d50cbac835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Use Gastroscope 3.5/2.0 85cm
• Version Model Number: LE
• Catalog Number: 1021
• Company DUNS: 117077970
• Company Name: Evoendo, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 85 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850031897076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213606

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-09
• Device Publish Date: 2024-08-30

Devices Manufactured by Evoendo, Inc.

• 00850031897076 - Single-Use Gastroscope 3.5/2.0 85cm: 2024-09-09The 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
• 00850031897076 - Single-Use Gastroscope 3.5/2.0 85cm: 2024-09-09 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult
• 00850031897083 - Single-Use Gastroscope 3.5/2.0 85cm 5-pack: 2024-09-09 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult
• 00850031897090 - Single-Use Gastroscope 3.5/2.0 85cm DEMO: 2024-09-09 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult
• 00850031897014 - EvoEndo Model LE Single-Use Gastroscope: 2022-03-07 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult
• 00850031897021 - EvoEndo Controller: 2022-03-07 The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the Ev
• 00850031897038 - EvoEndo Model LE Single-Use Gastroscope: 2022-03-07 The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult