NEC

GUDID 00805736045413

NEC DISPLAY SOLUTIONS, LTD.

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• Primary Device ID: 00805736045413
• NIH Device Record Key: 93189444-b249-433f-b6e0-fc8ea1aafe2c
• Commercial Distribution Discontinuation: 2017-11-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NEC
• Version Model Number: MD211G5
• Company DUNS: 691742001
• Company Name: NEC DISPLAY SOLUTIONS, LTD.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00805736045413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160326

FDA Product Code

• PGY: Display, Diagnostic Radiology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [NEC]

• 00805736060713: MD322C8
• 00805736059380: MD212C2
• 00805736054873: MD210C3
• 00805736053661: MD212G3
• 00805736052923: MD302C6
• 00805736051230: MD302C4
• 00805736046250: MD242C2
• 00805736045413: MD211G5
• 00805736044966: MD211C3
• 00805736044959: MD211C2