Midmark ClearVision Digital Sensor System XSDN-02

GUDID 00841709100390

Intraoral X-ray, Digital Imaging Sensor

MIDMARK CORPORATION

Dental digital imaging sensor, intraoral

• Primary Device ID: 00841709100390
• NIH Device Record Key: 2f9c2c24-68a9-4531-a8d0-5643113adea2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midmark ClearVision Digital Sensor System
• Version Model Number: XSDN-02
• Catalog Number: XSDN-02
• 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: true
• 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 -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841709100390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112380

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

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: 2016-09-23

On-Brand Devices [Midmark ClearVision Digital Sensor System]

• 00841709103728: Intraoral X-ray with Digital Imaging Sensor
• 00841709103711: Intraoral X-ray with Digital Imaging Sensor
• 00841709100925: Intraoral X-ray, Digital Imaging Sensor
• 00841709100918: Intraoral X-ray, Digital Imaging Sensor
• 00841709100468: Intraoral X-ray, Digital Imaging Sensor
• 00841709100437: Intraoral X-ray, Digital Imaging Sensor
• 00841709100420: Intraoral X-ray, Digital Imaging Sensor
• 00841709100406: Intraoral X-ray, Digital Imaging Sensor
• 00841709100390: Intraoral X-ray, Digital Imaging Sensor
• 00841709100383: Intraoral X-ray, Digital Imaging Sensor