ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

GUDID 04953170310386

LTF-S190-10 ENDOEYE FLEX 10 VIDEOSCOPE

OLYMPUS MEDICAL SYSTEMS CORP.

Rigid video laparoscope

• Primary Device ID: 04953170310386
• NIH Device Record Key: 4959e1b1-c520-485d-ba6f-f08c1d1f808f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Version Model Number: OLYMPUS LTF-S190-10
• 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
• 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	04953170310386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111425

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170310386]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

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 [ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE]

• 04953170310386: LTF-S190-10 ENDOEYE FLEX 10 VIDEOSCOPE
• 04953170310355: LTF-S190-5 ENDOEYE FLEX 5 HD VIDEOSCOPE
• 04953170434662: OLYMPUS LTF-S190-10
• 04953170434648: OLYMPUS LTF-S190-5