Solo 10-001

GUDID 00867359000309

JAZZ IMAGING LLC

Dental digital imaging sensor, intraoral

• Primary Device ID: 00867359000309
• NIH Device Record Key: 1f03c1ff-8da1-458c-bb6d-b9a8eba661b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solo
• Version Model Number: 10-001
• Catalog Number: 10-001
• Company DUNS: 079381473
• Company Name: JAZZ IMAGING LLC
• 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: 567-234-5299
• Email: info@jazzimaging.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867359000309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163224

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: 2019-08-07
• Device Publish Date: 2019-07-30