Rejuvacyn Plus 86007

GUDID 20850015491515

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial
Primary Device ID20850015491515
NIH Device Record Key68d40126-eb79-4378-a4c6-bcd64f272b25
Commercial Distribution StatusIn Commercial Distribution
Brand NameRejuvacyn Plus
Version Model Number86007
Catalog Number86007
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

Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 Gram
Weight40 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
GS100850015491511 [Primary]
GS120850015491515 [Package]
Contains: 00850015491511
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

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

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20850015491638 - Rejuvacyn Plus Dermal Spray2023-05-15
20850015491645 - Rejuvacyn Plus Dermal Spray2023-05-15
20850015491652 - Pediacyn Hydrogel Advanced Itch-Burn-Rash-Pain Relief2023-05-15
20850015491669 - Pediacyn Dermal Spray Advaced Skin & Wound Cleanser2023-05-15
20850015491676 - Podiacyn OTC Advanced Everyday Foot Care2023-05-15

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