EVIS EXERA III COLONOVIDEOSCOPE

GUDID 04953170420702

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable

• Primary Device ID: 04953170420702
• NIH Device Record Key: 49785b12-6aef-4929-9e1b-57ee6b7bf9b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Version Model Number: OLYMPUS PCF-H190TL
• 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
• 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	04953170420702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192793

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

[04953170420702]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [EVIS EXERA III COLONOVIDEOSCOPE]

• 04953170363696: OLYMPUS PCF-H190DI
• 04953170363672: OLYMPUS PCF-H190DL
• 04953170420719: OLYMPUS PCF-H190TI
• 04953170420702: OLYMPUS PCF-H190TL
• 04953170416132: OLYMPUS PCF-HQ190I
• 04953170416118: OLYMPUS PCF-HQ190L