ROOT ZX II OTR Module

GUDID 04548213022519

J.MORITA MFG.CORP.

Endodontic enlarger, reusable

• Primary Device ID: 04548213022519
• NIH Device Record Key: a466df9e-0c52-485c-b87b-d091d6a3a237
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROOT ZX II OTR Module
• Version Model Number: DP-ZX-VL
• Company DUNS: 693811465
• Company Name: J.MORITA MFG.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: true
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548213022519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071190

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

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: 2018-09-24
• Device Publish Date: 2016-08-31

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