Carina 5703122

GUDID 00304040165270

Digital X-Ray Sensor

HENRY SCHEIN, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: 00304040165270
• NIH Device Record Key: ff42dd7f-7276-4226-8833-239c8377c562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carina
• Version Model Number: 5703122
• Catalog Number: 5703122
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040165270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221955

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: 2022-11-10
• Device Publish Date: 2022-11-02

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