Endocyn Irrigation Solution P-E1176T00

GUDID 20850015491614

Sonoma Pharmaceuticals, Inc.

Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution

Primary Device ID	20850015491614
NIH Device Record Key	de029ca4-6c9e-4403-83a4-0ac992464fc3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Endocyn Irrigation Solution
Version Model Number	P-E1176T00
Catalog Number	P-E1176T00
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	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter
Total Volume	500 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015491610 [Primary]
GS1	20850015491614 [Package] Contains: 00850015491610 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

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

20850034960009 - Dr. Burd's Wonder Spray	2023-09-15
20850034960016 - Dr. Burd's Wonder Spray	2023-09-15
20850015491621 - Rejuvacyn Plus Antipruritic Spray Gel	2023-05-15
20850015491638 - Rejuvacyn Plus Dermal Spray	2023-05-15
20850015491645 - Rejuvacyn Plus Dermal Spray	2023-05-15
20850015491652 - Pediacyn Hydrogel Advanced Itch-Burn-Rash-Pain Relief	2023-05-15
20850015491669 - Pediacyn Dermal Spray Advaced Skin & Wound Cleanser	2023-05-15
20850015491676 - Podiacyn OTC Advanced Everyday Foot Care	2023-05-15