Midmark OptiMax Digital Sensor System XSDN-03

GUDID 00841709104367

CLEARVISION OPTIMAX SENSOR SYSTEM, SIZE #1, 0.9M CABLE

MIDMARK CORPORATION

Dental digital imaging sensor, intraoral

• Primary Device ID: 00841709104367
• NIH Device Record Key: b53233a3-90cc-438c-a34b-d53843095a1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midmark OptiMax Digital Sensor System
• Version Model Number: XSDN-03
• Catalog Number: XSDN-03
• 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 -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	00841709104367 [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: 2016-09-24

On-Brand Devices [Midmark OptiMax Digital Sensor System]

• 00841709104596: SENSOR SYSTEM, VETPRO OPTIMAX, SIZE #1 & #2, 3M CBL WITH LAPTOP
• 00841709104589: SENSOR SYSTEM VETPRO OPTIMAX, SIZE #1 AND #2, 3M CABLE
• 00841709104572: SENSOR SYSTEM, VETPRO OPTIMAX, SIZE #2, 3M CABLE WITH LAPTOP
• 00841709104565: SENSOR SYSTEM, VETPRO OPTIMAX, SIZE #2, 3M CABLE
• 00841709104558: SENSOR SYSTEM, VETPRO OPTIMAX, SIZE #1, 3 M CABLE WITH LAPTOP
• 00841709104541: SENSOR SYSTEM, VETPRO OPTIMAX, SIZE #1, 3M CABLE
• 00841709104534: SENSOR , VETPRO OPTIMAX, SIZE #2, 0.9M CABLE
• 00841709104527: SENSOR, VETPRO OPTIMAX, SIZE #1, 0.9M CABLE
• 00841709104510: SENSOR , VETPRO OPTIMAX, SIZE #2, 3M CABLE
• 00841709104503: SENSOR, VETPRO OPTIMAX, SIZE #1, 3M CABLE
• 00841709104497: SENSOR SYSTEM, VETPRO OPTIMAX, SIZE #2, 0.9M CABLE WITH LAPTOP
• 00841709104480: SENSOR SYSTEM VETPRO OPTIMAX, SIZE #2, 0.9M CABLE
• 00841709104473: SENSOR SYSTEM VETPRO OPTIMAX, SIZE #1, 0.9M CABLE WITH LAPTOP
• 00841709104466: SENSOR SYSTEM VETPRO OPTIMAX, SIZE #1, 0.9M CABLE
• 00841709104459: SENSOR SYSTEM CLEARVISION OPTIMAX, SIZE #1 AND SIZE #2, 3M CABLE
• 00841709104442: SENSOR SYSTEM CLEARVISION OPTIMAX, SIZE #2, 3M CABLE
• 00841709104435: SENSOR SYSTEM CLEARVISION OPTIMAX, SIZE #1, 3M CABLE
• 00841709104428: SENSOR, CLEARVISION OPTIMAX, SIZE #2, 0.9M CABLE
• 00841709104411: SENSOR , CLEARVISION OPTIMAX, SIZE #1, 0.9M CABLE
• 00841709104404: SENSOR CLEARVISION OPTIMAX SIZE #2, 3M CABLE
• 00841709104398: SENSOR SYSTEM CLEARVISION OPTIMAX, SIZE #1, 3M CABLE
• 00841709104381: SENSOR SYSTEM CLEARVISION OPTIMAX, SIZE #1 AND #2, .9M CABLE
• 00841709104374: SENSOR SYSTEM CLEARVISION OPTIMAX, SIZE #2, 0.9M CABLE
• 00841709104367: CLEARVISION OPTIMAX SENSOR SYSTEM, SIZE #1, 0.9M CABLE