EVIS EXERA lll COLONOVIDEOSCOPE

GUDID 04953170305214

"PCF-H190I EVIS EXERA III HD SLIM COLONOS"

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable

• Primary Device ID: 04953170305214
• NIH Device Record Key: 159dab42-b05e-4191-bd63-32ba23a91597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA lll COLONOVIDEOSCOPE
• Version Model Number: OLYMPUS PCF-H190I
• 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
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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
• 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	04953170305214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112680
• Premarket Notification: K131780

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

Ethylene Oxide;High-level Disinfectant

[04953170305214]

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 COLONOVIDEOSCOPE]

• 04953170305252: "PCF-PH190I ULTRA SLIM EE III HD COLONOSC"
• 04953170305238: "PCF-PH190L ULTRASLIM EE III HD COLONOSCO"
• 04953170305214: "PCF-H190I EVIS EXERA III HD SLIM COLONOS"
• 04953170305191: "PCF-H190L EVIS EXERA III HD SLIM COLONS."
• 04953170305177: OLYMPUS CF-H190I
• 04953170305153: OLYMPUS CF-H190L
• 04953170305139: CF-HQ190I EVIS EXERA III HD COLONOSCOPE
• 04953170305115: CF-HQ190L EVIS EXERA III HD COLONOSCOPE
• 04953170436710: OLYMPUS PCF-PH190I
• 04953170436697: OLYMPUS PCF-PH190L
• 04953170436673: OLYMPUS PCF-H190I
• 04953170436659: OLYMPUS PCF-H190L
• 04953170436635: OLYMPUS CF-H190I
• 04953170436611: OLYMPUS CF-H190L
• 04953170436598: OLYMPUS CF-HQ190I
• 04953170436574: OLYMPUS CF-HQ190L