Primocyn Eau Divine Skin Hydrogel 86004

GUDID 00850015491214

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID00850015491214
NIH Device Record Keye7b1f060-24ab-48a6-a270-4e8bb34807d0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimocyn Eau Divine Skin Hydrogel
Version Model Number86004
Catalog Number86004
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

Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram
Weight50 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015491214 [Primary]
GS120850015491218 [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 Hydrogel]

0086043900204085035
0085001549121486004

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