Gendex GXC-300™ intraoral camera GXC300

GUDID EKAV082243310

Digital intraoral camera

GENDEX CORP.

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• Primary Device ID: EKAV082243310
• NIH Device Record Key: b373d4bf-9daf-4897-95dd-0c13790d0340
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gendex GXC-300™ intraoral camera
• Version Model Number: 0.822.4331
• Catalog Number: GXC300
• Company DUNS: 144575763
• Company Name: GENDEX 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV082243310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040691

FDA Product Code

• EIA: UNIT, OPERATIVE DENTAL

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: 2016-09-24

On-Brand Devices [Gendex GXC-300™ intraoral camera]

• EKAV100719700: Digital intraoral cameraDigital intraoral camera
• EKAV082243310: Digital intraoral camera