ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE N3828033

GUDID 04953170434648

OLYMPUS MEDICAL SYSTEMS CORP.

Rigid video laparoscope

• Primary Device ID: 04953170434648
• NIH Device Record Key: ae9eb131-c1de-4c6d-82be-5d0c126d5e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Version Model Number: OLYMPUS LTF-S190-5
• Catalog Number: N3828033
• 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: false
• 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	04953170434648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201832

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

Sterilization

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

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

[04953170434648]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-22

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