Dr Sabrina Eye Regenerate LED mask

GUDID 05060534510838

Dr Sabrina Eye Regenerate LED mask- TN2189 (Wrinkle LED Eye Patch)

I-SMART DEVELOPMENTS LIMITED

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• Primary Device ID: 05060534510838
• NIH Device Record Key: 540824bd-07ec-47c8-93de-2bf174fc81e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr Sabrina Eye Regenerate LED mask
• Version Model Number: TN2189
• Company DUNS: 223616320
• Company Name: I-SMART DEVELOPMENTS LIMITED
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060534510838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231555

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

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: 2024-05-14
• Device Publish Date: 2024-05-06

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