Toothprint Wafer

GUDID 00858290006284

Toothprint Wafer Kit-48pk

ELEVATE ORAL CARE, LLC

Saliva absorbent

• Primary Device ID: 00858290006284
• NIH Device Record Key: 28492473-72e5-4669-80a4-9b44e7182f48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Toothprint Wafer
• Version Model Number: 660000480
• Company DUNS: 002863526
• Company Name: ELEVATE ORAL CARE, LLC
• Device Count: 48
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006284 [Primary]
GS1	00858290006291 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850915

FDA Product Code

• EGD: Wax, Dental, Intraoral

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: 2019-02-28
• Device Publish Date: 2019-01-28

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