NOMAD Pro2 Packaged X-Ray System Black-R

GUDID D090085006220

Dental Imaging Technologies Corporation

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• Primary Device ID: D090085006220
• NIH Device Record Key: 0ed861b2-fc0a-4664-a8fa-3b98b940aee0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOMAD Pro2 Packaged X-Ray System Black-R
• Version Model Number: 0.850.0622
• Company DUNS: 800111106
• Company Name: Dental Imaging Technologies Corporation
• 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: false
• 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
HIBCC	D090085006220 [Primary]
HIBCC	EKAV085006220 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173319

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2022-03-14
• Device Publish Date: 2022-03-04

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