FDA.reportPublic FDA data

SynePure Wound Cleanser

Primary DI
00852181005295
Brand
SynePure Wound Cleanser
Company
SYNEDGEN, INC.
Model
4oz
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
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
00852181005295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852181005295008521810052958521810052950852181005295

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.

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
00852181005301SynePure Wound Cleanser8 oz2020-10-01
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
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08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
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09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
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09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
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09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
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10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
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10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07