Endocyn Irrigation Solution P-E1176T00

GUDID 20850015491614

Sonoma Pharmaceuticals, Inc.

Root canal cleaning solution
Primary Device ID20850015491614
NIH Device Record Keyde029ca4-6c9e-4403-83a4-0ac992464fc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndocyn Irrigation Solution
Version Model NumberP-E1176T00
Catalog NumberP-E1176T00
Company DUNS081642964
Company NameSonoma Pharmaceuticals, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015491610 [Primary]
GS120850015491614 [Package]
Contains: 00850015491610
Package: Box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KJJCleanser, Root Canal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-02

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

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20850015491621 - Rejuvacyn Plus Antipruritic Spray Gel2023-05-15
20850015491638 - Rejuvacyn Plus Dermal Spray2023-05-15
20850015491645 - Rejuvacyn Plus Dermal Spray2023-05-15

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