OnDemand3DTM

GUDID 08800023100068

Cybermed Inc.

Radiology DICOM image processing application software

• Primary Device ID: 08800023100068
• NIH Device Record Key: e013d303-8708-41c1-b5d5-47117fa5d6fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnDemand3DTM
• Version Model Number: 1.0
• Company DUNS: 688248447
• Company Name: Cybermed 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-341-0623
• Email: alex@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800023100068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070464
• Premarket Notification: K210039

FDA Product Code

• DZE: Implant, Endosseous, Root-Form
• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-09
• Device Publish Date: 2018-02-09

On-Brand Devices [OnDemand3DTM]

• 88000231000068: 1.0
• 08800023100068: 1.0
• 08800023100006: 1.0