Gelclair® CONCENTRATED ORAL GEL

GUDID 00370564456156

Gelclair® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

Napo Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00370564456156
• NIH Device Record Key: 022ec077-563b-4cf7-80cc-7a38331b3352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gelclair® CONCENTRATED ORAL GEL
• Version Model Number: 15 x 15mL Single-dose sachets
• Company DUNS: 170787530
• Company Name: Napo Pharmaceuticals, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com
• Phone: 4159639938
• Email: trade@napopharma.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370564456156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013056

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: 2024-09-23
• Device Publish Date: 2024-09-13