Midmark Extraoral Imaging System (EOIS) 60-A1041

GUDID 00841709118449

MIDMARK CORPORATION

Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 00841709118449
• NIH Device Record Key: 55c6f6a3-e0ee-478c-8dfc-83f89a258867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midmark Extraoral Imaging System (EOIS)
• Version Model Number: 60-A1041
• Catalog Number: 60-A1041
• 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: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com
• Phone: +1(800)643-6275
• Email: support@midmark.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841709118449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201667

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-29
• Device Publish Date: 2020-12-21

On-Brand Devices [Midmark Extraoral Imaging System (EOIS)]

• 00841709118401: 60-A0012
• 00841709118470: 60-A1038
• 00841709118463: 60-A1032
• 00841709118456: 60-A1031
• 00841709118418: 60-A1037
• 00841709118500: 60-A1026
• 00841709118494: 60-A2154
• 00841709118487: 60-A2116
• 00841709118449: 60-A1041
• 00841709118395: 60-A0012 / 60-A0016 / 60-A1041
• 00841709118388: 60-A0012 / 60-A0016
• 00841709118371: 60-A0012 / 60-A0015 / 60-A1041
• 00841709118364: 60-A0012 / 60-A0015
• 00841709118357: 60-A0012 / 60-A1037 / 60-A1041
• 00841709118340: 60-A0012 / 60-A1037
• 00841709118432: 60-A0016
• 00841709118425: 60-A0015