PREVA 2.0, MOBILE RETROFIT KIT XSAM‐G0

GUDID 00841709103155

"Retrofit Kit for Gray, Mobile, Intraoral System"

MIDMARK CORPORATION

Mobile intraoral dental x-ray system, digital

• Primary Device ID: 00841709103155
• NIH Device Record Key: b48f0c14-b772-4958-9833-e2ef530ca7ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVA 2.0, MOBILE RETROFIT KIT
• Version Model Number: XSAM‐G0
• Catalog Number: XSAM‐G0
• 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	00841709103155 [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

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