SynePure Wound Cleanser

GUDID 00852181005295

SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

SYNEDGEN, INC.

Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute
Primary Device ID00852181005295
NIH Device Record Key187ea90a-67f2-4ea3-9088-b15b6f7febab
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynePure Wound Cleanser
Version Model Number4oz
Company DUNS830276353
Company NameSYNEDGEN, 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 Productfalse
Single Usetrue
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

Customer Support Contacts

Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com
Phone855-774-7962
Emailinfo@synedgen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852181005295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-10-09
Device Publish Date2020-10-01

On-Brand Devices [SynePure Wound Cleanser]

00852181005301SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pr
00852181005295SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pr
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.