EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

GUDID 04953170307522

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 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: 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