EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE N3803041

GUDID 04953170436758

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope

• Primary Device ID: 04953170436758
• NIH Device Record Key: c8b13ba8-8b11-4ce5-bfbc-05e2549b221c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Version Model Number: OLYMPUS GIF-H190
• Catalog Number: N3803041
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170436758 [Primary]

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

Sterilization

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

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

[04953170436758]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-22

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