BioStom

GUDID 00370275850250

BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services.

Forward Science Technologies LLC

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 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 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: 00370275850250
• NIH Device Record Key: eda026dd-3e50-4819-8a97-6a13a0b6f4df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioStom
• Version Model Number: BioStom 25ct
• Company DUNS: 079212068
• Company Name: Forward Science Technologies LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370275850250 [Primary]

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: 2024-02-22
• Device Publish Date: 2024-02-14

On-Brand Devices [BioStom]

• 00370275850502: BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel
• 00370275850250: BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel
• 00370275850106: BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel