Xcam

GUDID 08800005200175

This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures.

HDX WILL CORP.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 08800005200175
• NIH Device Record Key: 38081363-6f57-4070-b278-699e09f30a8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xcam
• Version Model Number: Xcam
• Company DUNS: 689605054
• Company Name: HDX WILL 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: 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: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800005200175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192700

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2021-05-06
• Device Publish Date: 2021-04-28

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