EVIS EXERA II COLONOVIDEOSCOPE

GUDID 04953170237300

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable

• Primary Device ID: 04953170237300
• NIH Device Record Key: e8288a0b-3415-4c3e-9f43-873a2d0fc413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Version Model Number: OLYMPUS PCF TYPE H180AI
• 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
• 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	04953170237300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100584

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

Ethylene Oxide;High-level Disinfectant

[04953170237300]

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 [EVIS EXERA II COLONOVIDEOSCOPE]

• 04953170339905: "PCF-H180AL EVIS EXERA II COLONOSCOPE"
• 04953170339899: OLYMPUS PCF TYPE H180AL
• 04953170339882: "PCF-H180AI EVIS EXERA II ULTRA THIN CLNV"
• 04953170339875: OLYMPUS PCF TYPE H180AI
• 04953170339653: CF-H180DL EVIS EXERA II COLONOSCOPE
• 04953170339639: OLYMPUS CF TYPE H180DI
• 04953170339615: CF-H180AL EVIS EXERA II HD COLONOSCOPE
• 04953170339608: OLYMPUS CF TYPE H180AL
• 04953170339592: CF-H180AI EVIS EXERA II HD COLONOSCOPE
• 04953170339585: OLYMPUS CF TYPE H180AI
• 04953170339189: "PCF-Q180AL EVIS EXERA II COLONOSCOPE"
• 04953170339172: "PCF-Q180AI EVIS EXERA II COLONOSCOPE"
• 04953170307720: OLYMPUS PCF TYPE Q180AL
• 04953170307713: OLYMPUS PCF TYPE Q180AI
• 04953170307706: OLYMPUS CF TYPE Q180AL
• 04953170307690: OLYMPUS CF TYPE Q180AI
• 04953170237300: OLYMPUS PCF TYPE H180AI
• 04953170237294: OLYMPUS PCF TYPE H180AL
• 04953170237287: OLYMPUS PCF TYPE H180AL
• 04953170202544: OLYMPUS PCF TYPE Q180AL
• 04953170202506: OLYMPUS CF TYPE H180AI
• 04953170202445: OLYMPUS CF TYPE H180AL
• 04953170202339: OLYMPUS CF TYPE H180AL
• 04953170202315: OLYMPUS CF TYPE Q180AL