Microcyn Skin & Wound HydroGel 84750

GUDID 20189116000754

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID20189116000754
NIH Device Record Keyc2fa76b2-8c44-4bb0-b9ea-04f4641e5ed4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicrocyn Skin & Wound HydroGel
Version Model Number84750
Catalog Number84750
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram
Weight43 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100189116000750 [Primary]
GS120189116000754 [Package]
Contains: 00189116000750
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 Date2022-12-09
Device Publish Date2022-12-01

On-Brand Devices [Microcyn Skin & Wound HydroGel]

2018911600080884804
2018911600075484750
00850015491122P-E1210T00
20850015491072P-E1197T00

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.