LunaGuard 1030

GUDID 00033732010306

McKeon Products, Inc.

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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