EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

GUDID 04953170307492

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video gastroduodenoscope

• Primary Device ID: 04953170307492
• NIH Device Record Key: 3e1201e8-af1c-465c-8516-5d1a54fdc13d
• 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	04953170307492 [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

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

High-level Disinfectant;Ethylene Oxide

[04953170307492]

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