GUDID 06974803440001

Shenzhen Yinuo Dental Technology Co.LTD

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• Primary Device ID: 06974803440001
• NIH Device Record Key: f556b4ab-ceef-41cf-8130-ec8fb81746fe
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: V1.0
• Company DUNS: 412473497
• Company Name: Shenzhen Yinuo Dental Technology Co.LTD
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974803440001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210373

FDA Product Code

• NXC: Aligner, Sequential

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: 2021-11-08
• Device Publish Date: 2021-10-29