Canker-X Mouth Sore Gel

GUDID 00358962301001

Canker-X Mouth Sore Gel 8ml

Alliance Pharma Inc.

General oral wound dressing, non-animal-derived

• Primary Device ID: 00358962301001
• NIH Device Record Key: fe639905-3681-48ed-b43d-8ca9b31b8c33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Canker-X Mouth Sore Gel
• Version Model Number: Lot Code
• Company DUNS: 081138954
• Company Name: Alliance Pharma 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: 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00358962301001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040950

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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: 2024-04-10
• Device Publish Date: 2024-04-02

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