EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

GUDID 04953170307522

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video gastroduodenoscope

• Primary Device ID: 04953170307522
• NIH Device Record Key: 707cc2e1-4bdc-4e32-b0b8-7b29761c547b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Version Model Number: OLYMPUS GIF TYPE Q180
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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
• 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	04953170307522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100584

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid

Sterilization

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

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

[04953170307522]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE]

• 04953170339776: GIF-H180 HDTV NBI GASTROVIDEOSCOPE
• 04953170339769: OLYMPUS GIF TYPE H180
• 04953170339752: GIF-2TH180 THERAPEUTIC 2-CHANNEL HDTV GA
• 04953170339745: OLYMPUS GIF TYPE 2TH180
• 04953170339110: GIF-H180J GASTROSCOPE HDTV, WATER JET
• 04953170339097: GIF-XP180N 5.5MM GSTROSCPE 4-WAY, NBI
• 04953170339080: GIF-N180 ULTRA-SLIM GASTROVIDEOSCOPE
• 04953170307539: OLYMPUS GIF TYPE H180J
• 04953170307522: OLYMPUS GIF TYPE Q180
• 04953170307515: OLYMPUS GIF TYPE XP180N
• 04953170307508: OLYMPUS GIF TYPE N180
• 04953170275470: OLYMPUS GIF TYPE 2TH180
• 04953170275463: OLYMPUS GIF TYPE 2TH180
• 04953170275456: OLYMPUS GIF TYPE H180J
• 04953170275449: OLYMPUS GIF TYPE H180J
• 04953170275425: OLYMPUS GIF TYPE XP180N
• 04953170202285: OLYMPUS GIF TYPE H180
• 04953170202278: OLYMPUS GIF TYPE N180
• 04953170202261: OLYMPUS GIF TYPE N180
• 04953170202247: OLYMPUS GIF TYPE Q180