TOUCH PANEL FOR ENDOALPHA

GUDID 04953170291470

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic control/video-imaging system

• Primary Device ID: 04953170291470
• NIH Device Record Key: ea3ca1a8-c8bd-4de0-af03-a78643b83ac5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOUCH PANEL FOR ENDOALPHA
• Version Model Number: MAJ-1828
• 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: true
• Serial Number: false
• 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
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170291470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100345

FDA Product Code

• ODA: endoscopic central control unit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-21

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