EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

GUDID 04953170066610

GIF-2T160 THERAPEUTIC VIDEO GASTROSCOPE

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 Flexible video gastroduodenoscope

• Primary Device ID: 04953170066610
• NIH Device Record Key: 29522b5f-6d3f-420d-aac2-77d9d6c04625
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA GASTROINTESTINAL VIDEOSCOPE
• Version Model Number: OLYMPUS GIF TYPE 2T160
• 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
• 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	04953170066610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954451

FDA Product Code

• FET: Endoscopic video imaging system/component, gastroenterology-urology

Sterilization

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

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

[04953170066610]

High-level Disinfectant;Ethylene Oxide

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 GASTROINTESTINAL VIDEOSCOPE]

• 04953170339837: GIF-XTQ160 6.0MM CHANNEL GASTROSCOPE
• 04953170307492: OLYMPUS GIF TYPE 2T160
• 04953170156120: OLYMPUS GIF TYPE XTQ160
• 04953170066795: OLYMPUS GIF TYPE Q160Z
• 04953170066610: GIF-2T160 THERAPEUTIC VIDEO GASTROSCOPE