GASTROINTESTINAL VIDEOSCOPE N6129040

GUDID 04953170423628

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video gastroduodenoscope

• Primary Device ID: 04953170423628
• NIH Device Record Key: 930a44ce-8241-48d1-b06a-21a2cf548272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Version Model Number: OLYMPUS GIF-EZ1500
• Catalog Number: N6129040
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170423628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250432

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid

Sterilization

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

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

[04953170423628]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-03
• Device Publish Date: 2025-05-26

On-Brand Devices [GASTROINTESTINAL VIDEOSCOPE]

• 04953170334115: GIF-H170
• 04953170307485: GIF-Q150
• 04953170307478: GIF-XP150N
• 04953170229442: GIF-XP150N
• 04953170229435: GIF-Q150
• 04953170420191: OLYMPUS GIF-1100
• 04953170423628: OLYMPUS GIF-EZ1500