OroGenix Antiplaque Tooth Gel P-E1215T00

GUDID 20850015491140

Sonoma Pharmaceuticals, Inc.

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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