FDA.reportPublic FDA data

SynePure Wound Cleanser

Primary DI
00852181005301
Brand
SynePure Wound Cleanser
Company
SYNEDGEN, INC.
Model
8 oz
Device description
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.
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143444000SynePure Wound CleanserSynedgen, Inc.2015-08-21FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852181005301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852181005301008521810053018521810053010852181005301

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, multiple solute, non-sterileA non-sterile solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume8Fluid Ounce

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-774-7962info@synedgen.com

Regulatory Flags#

DUNS number
830276353
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852181005295SynePure Wound Cleanser4oz2020-10-01
00852181005332Catasyn (3oz)3 oz2021-03-01
00852181005097Moisyn Dry Mouth Oral Rinse300mL2020-12-22
00852181005134Moisyn Dry Mouth Oral Mist60mL2020-12-22
00852181005141Moisyn Dry Mouth Oral Rinse59.12020-12-22
00852181005042Moisyn Dry Mouth Oral Rinse60ML2020-09-22
00852181005059Moisyn Dry Mouth Oral Mist30mL2020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990802Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990895Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
00361470000175Amerigel Saline Wound WashAmerx Health Care Corp.FRO2026-06-22
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03