EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE

GUDID 04953170305313

GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI

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

• Primary Device ID: 04953170305313
• NIH Device Record Key: 5c732817-cfe8-41ea-befd-5c50cad30113
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE
• Version Model Number: OLYMPUS GIF-XP190N
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170305313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123317

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid

Sterilization

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

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

[04953170305313]

Ethylene Oxide;High-level Disinfectant

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 lll GASTROINTESTINAL VIDEOSCOPE]

• 04953170305313: GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI
• 04953170436772: OLYMPUS GIF-XP190N