AccessGUDID - DEVICE: MEDISONO (B369MES01014)

GUDID

Device Identifier (DI) Information

Brand Name: MEDISONO
Version or Model: Medisono END-VYS EG-500L Gastroscope
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MES01014
Company Name: Medisono, LLC

Primary DI Number: B369MES01014
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079686615 *Terms of Use

Device Description: Medisono END-VYS EG-500L Gastroscope

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35088	Flexible fibreoptic gastroscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. It is inserted into the body through the mouth during gastroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in the evaluation or treatment of unusual abdominal pain, bleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia. Physicians may also use the device to obtain biopsies or perform other procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDS	Gastroscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211882	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90cbb2ec-b5b1-4da0-849d-186afd168d01
Public Version Date: March 23, 2026
Public Version Number: 2
DI Record Publish Date: November 17, 2023