FireCR Dental CG-702

GUDID 08809466040214

The advanced CR technology of the FireCR Dental Reader 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, reusable bitewings and intraoral imaging plates. The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for seamless device operation.

Digiray Corp.

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• Primary Device ID: 08809466040214
• NIH Device Record Key: 466db956-9311-4494-9654-ea80ed0b7bf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FireCR Dental
• Version Model Number: FR11
• Catalog Number: CG-702
• Company DUNS: 557815751
• Company Name: Digiray Corp.
• 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: 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
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr
• Phone: 0427103763
• Email: kiwnd@digiray.co.kr

Device Dimensions

• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter
• Weight: 4.7 Kilogram
• Width: 12 Centimeter
• Length: 31.8 Centimeter
• Height: 26.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809466040214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131442

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: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-02-07
• Device Publish Date: 2016-06-22

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