OroGenix Oral Hygiene Rinse P-E1216T00

GUDID 20850015491157

Sonoma Pharmaceuticals, Inc.

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Primary Device ID	20850015491157
NIH Device Record Key	5681f7f9-f535-4bf1-a0ca-eda81c5cd5df
Commercial Distribution Status	In Commercial Distribution
Brand Name	OroGenix Oral Hygiene Rinse
Version Model Number	P-E1216T00
Catalog Number	P-E1216T00
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

Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter
Total Volume	237 Milliliter

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	00850015491153 [Primary]
GS1	20850015491157 [Package] Contains: 00850015491153 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

On-Brand Devices [OroGenix Oral Hygiene Rinse]

20850015491164	P-E1217T00
20850015491157	P-E1216T00