Nomad Pro2 Packaged System, GBL 1.013.2041

GUDID D090101320410

Nomad Pro2 Packaged System, GBL

Dental Imaging Technologies Corporation

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• Primary Device ID: D090101320410
• NIH Device Record Key: 0d27cafd-a2e5-4c76-8ec0-195a680092f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nomad Pro2 Packaged System, GBL
• Version Model Number: 1.013.2041
• Catalog Number: 1.013.2041
• 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: 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
HIBCC	D090101320410 [Primary]

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: 2023-03-16
• Device Publish Date: 2023-03-08

Devices Manufactured by Dental Imaging Technologies Corporation

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• D090800025780 - DEXIS Ti2 Sensor Kit: 2024-01-31 DEXIS Ti2 Warranty Replacement NEW
• D090800025790 - DEXIS Ti2 Sensor Kit: 2024-01-31 Upgrade Kit, Sensor to Ti2
• D090800025800 - DEXIS Ti2 Sensor Kit: 2024-01-31 DEXIS Ti2 Warranty Replacement - R
• D090800025840 - DEXIS Ti2 Sensor Kit: 2024-01-31 Upgrade Kit, Platinum to Ti2
• 00693856000302 - CS MODEL+: 2023-12-21 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
• D090800025720 - DEXIS Ti2 Sensor: 2023-12-20