EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

GUDID 04953170305290

GIF-H190 EVIS EXERA III HDTV GASTROSCOPE

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video gastroduodenoscope

• Primary Device ID: 04953170305290
• NIH Device Record Key: 2fa84634-faf0-4ba5-91bd-456c1c70871f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Version Model Number: OLYMPUS GIF-H190
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170305290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112680

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

[04953170305290]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE]

• 04953170343360: GIF-1TH190 GIF-1TH190 EVIS EXERA III HIG
• 04953170305290: GIF-H190 EVIS EXERA III HDTV GASTROSCOPE
• 04953170305276: GIF-HQ190 EVIS EXERA III HDTV DF NBI
• 04953170437014: OLYMPUS GIF-1TH190
• 04953170436758: OLYMPUS GIF-H190
• 04953170436734: OLYMPUS GIF-HQ190
• 04953170452475: OLYMPUS GIF-1TH190