4K UHD LCD MONITOR

GUDID 04953170418723

OLYMPUS MEDICAL SYSTEMS CORP.

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• Primary Device ID: 04953170418723
• NIH Device Record Key: ee18bfb3-071f-46f7-9647-c44b2763022d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4K UHD LCD MONITOR
• Version Model Number: OEV321UH
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170418723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220069

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-13
• Device Publish Date: 2022-04-05

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