OroGenix Antiplaque Tooth Gel P-E1215T00

GUDID 20850015491140

Sonoma Pharmaceuticals, Inc.

Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash Dental mouthwash

• Primary Device ID: 20850015491140
• NIH Device Record Key: 9550836e-1de8-4a49-a5ac-6998b146d21f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OroGenix Antiplaque Tooth Gel
• Version Model Number: P-E1215T00
• Catalog Number: P-E1215T00
• Company DUNS: 081642964
• Company Name: Sonoma 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: false
• 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 Dimensions

• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram
• Weight: 86 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015491146 [Primary]
GS1	20850015491140 [Package]; Contains: 00850015491146; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141352

FDA Product Code

• KJJ: Cleanser, Root Canal

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: 2022-12-12
• Device Publish Date: 2022-12-02

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