PREVA 2.0 MOBILE WHT RETROFIT XSAM‐W0

GUDID 00841709103162

Retrofit Kit for White Mobile, Intraoral System

MIDMARK CORPORATION

Mobile intraoral dental x-ray system, digital

• Primary Device ID: 00841709103162
• NIH Device Record Key: 78db8507-1498-421c-90ac-8c414accdff7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVA 2.0 MOBILE WHT RETROFIT
• Version Model Number: XSAM‐W0
• Catalog Number: XSAM‐W0
• 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: 1-800-634-6275
• 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	00841709103162 [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: 2016-09-23

Devices Manufactured by MIDMARK CORPORATION

• 00841709122958 - Midmark: 2025-06-12 The standard articulating headrest allows you to tilt the patient's head or adjust for different procedures, helping improve ac
• 00841709122965 - Midmark: 2025-06-12 The standard articulating headrest allows you to tilt the patient's head or adjust for different procedures, helping improve ac
• 00841709122972 - Midmark: 2025-06-12 The standard articulating headrest allows you to tilt the patient's head or adjust for different procedures, helping improve ac
• 00841709122989 - Midmark: 2025-06-12 The standard articulating headrest allows you to tilt the patient's head or adjust for different procedures, helping improve ac
• 00841709122996 - Midmark: 2025-06-12 The standard articulating headrest allows you to tilt the patient's head or adjust for different procedures, helping improve ac
• 00841709123009 - Midmark: 2025-06-12 The standard articulating headrest allows you to tilt the patient's head or adjust for different procedures, helping improve ac
• 00841709123016 - Midmark: 2025-06-12 The standard articulating headrest allows you to tilt the patient's head or adjust for different procedures, helping improve ac
• 00841709123023 - Midmark: 2025-06-12 The standard articulating headrest allows you to tilt the patient's head or adjust for different procedures, helping improve ac