LunaGuard 1030

GUDID 00033732010306

McKeon Products, Inc.

Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable

• Primary Device ID: 00033732010306
• NIH Device Record Key: 049600d0-8d7c-4a97-a1d8-60280b1ad2ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LunaGuard
• Version Model Number: Nighttime Dental Guard
• Catalog Number: 1030
• Company DUNS: 006522122
• Company Name: McKeon Products, 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: false
• Manufacturing Date: false
• 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	00033732010306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191033

FDA Product Code

• OBR: Mouthguard, Over-The-Counter

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: 2022-10-17
• Device Publish Date: 2022-10-07

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