ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

GUDID 04953170310386

LTF-S190-10 ENDOEYE FLEX 10 VIDEOSCOPE

OLYMPUS MEDICAL SYSTEMS CORP.

Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope 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