EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

GUDID 04953170237423

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video enteroscope

• Primary Device ID: 04953170237423
• NIH Device Record Key: eaf2131f-ae75-478a-bf6a-dcd1bb170bf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
• Version Model Number: OLYMPUS SIF TYPE Q180
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170237423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071254

FDA Product Code

• FDA: Enteroscope and accessories

Sterilization

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

[04953170237423]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-21

On-Brand Devices [EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE]

• 04953170339943: "SIF-Q180 SMALL INTESTINAL VIDEOSCOPE WIT"
• 04953170339936: OLYMPUS SIF TYPE Q180
• 04953170242526: OLYMPUS SIF TYPE Q180
• 04953170237423: OLYMPUS SIF TYPE Q180