Primocyn Eau Divine Skin Solution 85003

GUDID 00189116000231

Sonoma Pharmaceuticals, Inc.

Non-antimicrobial wound irrigation solution, multiple solute
Primary Device ID00189116000231
NIH Device Record Keyc446a77d-f638-4d06-9194-0176502f32b8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimocyn Eau Divine Skin Solution
Version Model Number85003
Catalog Number85003
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 Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter
Total Volume89 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100189116000231 [Primary]
GS120189116000235 [Package]
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

FRODressing, Wound, Drug

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

On-Brand Devices [Primocyn Eau Divine Skin Solution ]

0018911600023185003
0018911600016384887
0018911600015684891
0018911600014984890

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