Canker-X Mouth Sore Spray

GUDID 00358962303005

Canker-X Mouth Sore Spray 15ml

Alliance Pharma Inc.

General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived General oral wound dressing, non-animal-derived

• Primary Device ID: 00358962303005
• NIH Device Record Key: fb7bd944-7e47-4998-852e-56d8be690460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Canker-X Mouth Sore Spray
• 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	00358962303005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042722

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: 2024-04-15
• Device Publish Date: 2024-04-05

Devices Manufactured by Alliance Pharma Inc.

• 00070030511746 - Kelo-cote Advanced Formula Scar Gel: 2024-04-18 Kelo-cote Advanced Formula Scar Gel 10g
• 00070030511753 - Kelo-cote Advanced Formula Scar Gel: 2024-04-18 Kelo-cote Advanced Formula Scar Gel 60g
• 00358962203060 - ScarAway Silicone Scar Gel for Kids: 2024-04-18 ScarAway Silicone Scar Gel 6g Kids
• 00358962203152 - ScarAway Silicone Acne Scar Gel: 2024-04-18 ScarAway Silicone Scar Gel 15g Acne
• 00358962203206 - ScarAway Silicone Scar Gel: 2024-04-18 ScarAway Silicone Scar Gel 20g AP
• 00358962204104 - ScarAway Silicone Scar Gel: 2024-04-18 ScarAway Silicone Scar Gel Tube 10g Single CA
• 00358962302008 - Canker-X Rincinol Mouth Sore Rinse: 2024-04-15 Canker-X Rincinol Mouth Sore Rinse 120ml
• 00358962303005 - Canker-X Mouth Sore Spray: 2024-04-15Canker-X Mouth Sore Spray 15ml
• 00358962303005 - Canker-X Mouth Sore Spray: 2024-04-15 Canker-X Mouth Sore Spray 15ml