COLONOVIDEOSCOPE

GUDID 04953170307621

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable

• Primary Device ID: 04953170307621
• NIH Device Record Key: 5bd657c2-0921-434a-a2bd-ead8f50ff129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLONOVIDEOSCOPE
• Version Model Number: CF-Q150I
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170307621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001241

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

[04953170307621]

Ethylene Oxide;High-level Disinfectant

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 [COLONOVIDEOSCOPE]

• 04953170334184: CF-H170I
• 04953170334160: CF-H170L
• 04953170312410: OLYMPUS CF-LV1I
• 04953170312397: OLYMPUS CF-LV1L
• 04953170307638: CF-Q150L
• 04953170307621: CF-Q150I
• 04953170229473: CF-Q150I
• 04953170229466: CF-Q150L
• 04953170424298: OLYMPUS CF-HQ1100DI
• 04953170424281: OLYMPUS CF-HQ1100DL