EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

GUDID 04953170339936

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope Flexible video enteroscope

• Primary Device ID: 04953170339936
• NIH Device Record Key: 08a681c4-ce63-4fac-9b0f-77c962654dcb
• 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
• 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	04953170339936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071254

FDA Product Code

• FED: endoscopic access overtube, gastroenterology-urology

Sterilization

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

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

[04953170339936]

Ethylene Oxide;High-level Disinfectant

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