COLONOVIDEOSCOPE

GUDID 04953170312410

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable

• Primary Device ID: 04953170312410
• NIH Device Record Key: 6bebe9aa-5680-421a-b400-b3d3ebefb71d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLONOVIDEOSCOPE
• Version Model Number: OLYMPUS CF-LV1I
• 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
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• 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
• 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	04953170312410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111756

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

[04953170312410]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2017-10-10

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