Midmark Intraoral Digital Sensor XSDS-0D

GUDID 00841709121678

MIDMARK CORPORATION

Dental digital imaging sensor, intraoral

• Primary Device ID: 00841709121678
• NIH Device Record Key: d5c1be97-e063-4e27-a86a-5e2ed1dbe82b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midmark Intraoral Digital Sensor
• Version Model Number: XSDS-0D
• Catalog Number: XSDS-0D
• 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
• 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	00841709121678 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

On-Brand Devices [Midmark Intraoral Digital Sensor]

• 00841709121302: XSVS-08/L
• 00841709121296: XSVS-06/L
• 00841709121289: XSDS-0D/L
• 00841709121272: XSDS-0D
• 00841709121265: XSDS-06/L
• 00841709121258: XSDS-05/L
• 00841709121241: Midmark BR IO Snsr, Size 2, 1.1M Cable, Vet, Sensor Only - Field Replacement Unit
• 00841709121234: Midmark IO DR Sensor, Size 2, 1.1M Cable, Vet, Sensor Only - Field Replacement Unit
• 00841709121227: Midmark BR IO Snsr, Size 2, 3M Cable, Vet, Sensor Only - Field Replacement Unit
• 00841709121210: Midmark IO DR Sensor, Size 2, 3M Cable, Vet, Sensor Only - Field Replacement Unit
• 00841709121203: Midmark IO Sensor, Size 2, 1.1m Cable, Dental, Sensor Only - Field Replacement Unit
• 00841709121197: Midmark IO Sensor, Size 1, 1.1m Cable, Dental, Sensor Only - Field Replacement Unit
• 00841709121180: Midmark IO Sensor, Size 2, 3m Cable, Dental, Sensor Only - Field Replacement Unit
• 00841709121173: Midmark IO Sensor, Size 1, 3m Cable, Dental, Sensor Only - Field Replacement Unit
• 00841709121166: XSVS-08
• 00841709121159: XSVS-06
• 00841709121142: XSVN-08
• 00841709121135: XSVN-06
• 00841709121128: XSDS-6
• 00841709121111: XSDS-05
• 00841709121104: XSDN-06
• 00841709121098: XSDN-05
• 00841709121661: XSVN-06/L
• 00841709121654: XSVN-06/L
• 00841709121685: XSDS-0D/L
• 00841709121678: XSDS-0D