Midmark PREVA 2.0 IntraOral Dental X-ray System DCD8-W2Z/H

GUDID 00841709101304

Intraoral X-ray

MIDMARK CORPORATION

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 00841709101304
• NIH Device Record Key: 1ef586c0-3914-4885-b211-8dd22d64419a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midmark PREVA 2.0 IntraOral Dental X-ray System
• Version Model Number: DCD8-W2Z/H
• Catalog Number: DCD8-W2Z/H
• Company DUNS: 005036025
• Company Name: MIDMARK 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-643-6275
• Email: imagingtechsupport@midmark.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -35 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -35 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -35 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -35 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841709101304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043092

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Midmark PREVA 2.0 IntraOral Dental X-ray System]

• 00841709104107: Intraoral X-ray
• 00841709104091: Intraoral X-ray
• 00841709104084: Intraoral X-ray
• 00841709104077: Intraoral X-ray
• 00841709104060: Intraoral X-ray
• 00841709104053: Intraoral X-ray
• 00841709104046: Intraoral X-ray
• 00841709104039: Intraoral X-ray
• 00841709101366: Intraoral X-ray
• 00841709101359: Intraoral X-ray
• 00841709101342: Intraoral X-ray
• 00841709101335: Intraoral X-ray
• 00841709101328: Intraoral X-ray
• 00841709101311: Intraoral X-ray
• 00841709101304: Intraoral X-ray
• 00841709101298: Intraoral X-ray
• 00841709101281: Intraoral X-ray
• 00841709101274: Intraoral X-ray
• 00841709101267: Intraoral X-ray
• 00841709101250: Intraoral X-ray
• 00841709101243: Intraoral X-ray
• 00841709101236: Intraoral X-ray
• 00841709101229: Intraoral X-ray
• 00841709101212: Intraoral X-ray
• 00841709101205: Intraoral X-ray
• 00841709101199: Intraoral X-ray
• 00841709101182: Intraoral X-ray
• 00841709101175: Intraoral X-ray
• 00841709101168: Intraoral X-ray
• 00841709101151: Intraoral X-ray
• 00841709101144: Intraoral X-ray
• 00841709101137: Intraoral X-ray
• 00841709101120: Intraoral X-ray
• 00841709101113: Intraoral X-ray
• 00841709101106: Intraoral X-ray
• 00841709101090: Intraoral X-ray
• 00841709101083: Intraoral X-ray
• 00841709101076: Intraoral X-ray
• 00841709101069: Intraoral X-ray
• 00841709101052: Intraoral X-ray
• 00841709101045: Intraoral X-ray
• 00841709101038: Intraoral X-ray
• 00841709101021: Intraoral X-ray
• 00841709101014: Intraoral X-ray
• 00841709100574: Intraoral X-ray
• 00841709100567: Intraoral X-ray