AccessGUDID - DEVICE: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE (04953170343360)

GUDID

Device Identifier (DI) Information

Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Version or Model: OLYMPUS GIF-1TH190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N4505840
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170343360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: GIF-1TH190 GIF-1TH190 EVIS EXERA III HIG

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	Yes
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?
38805	Flexible video gastroduodenoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It can be end-viewing (looking forward) or side-viewing (looking to one side) and is used for the cannulation of the pancreas and bile duct. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDS	Gastroscope And Accessories, Flexible/Rigid
NWB	Endoscope, Accessories, Narrow Band Spectrum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232997	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide

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: 4d2a41f5-6b42-43c7-8df9-2409df164c84
Public Version Date: June 27, 2024
Public Version Number: 5
DI Record Publish Date: September 21, 2016