FireCam HD Intraoral Camera

GUDID 08809466040610

The advanced camera & optics technology of the FireCam HD IntraOral Camera enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost. The design features a 360° touch-switch for capture operation.

Digiray Corp.

Surgical video camera

• Primary Device ID: 08809466040610
• NIH Device Record Key: 5e0eaaf6-1430-4f76-90e6-e7345ff9a825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FireCam HD Intraoral Camera
• Version Model Number: FR61
• Company DUNS: 557815751
• Company Name: Digiray Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: 0427103763
• Email: kiwnd@digiray.co.kr

Device Dimensions

• Weight: 120 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809466040610 [Primary]

FDA Product Code

• EAX: Mirror, Mouth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-07
• Device Publish Date: 2016-06-30

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