FDA.reportPublic FDA data

Puracyn® Plus OTC

Primary DI
00852009002475
Brand
Puracyn® Plus OTC
Company
Innovacyn, Inc.
Model
6001
Published
2026-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K133542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133542000PURACYN PLUS SKIN AND WOUNDInnovacyn, Inc.2014-04-28FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852009002472PackageGS112In Commercial Distribution
00852009002475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085200900247210852009002472
00852009002475008520090024758520090024750852009002475

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
866-787-2296customerservice@innovacyn.com

Regulatory Flags#

DUNS number
025217003
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818582012867Puracyn® Plus OTC60072026-07-17
00818582012881Puracyn® Plus OTC60432026-07-17
00852009002451Puracyn® Plus OTC60022026-07-17
00852009002536Puracyn® Plus OTC60042026-07-17
00818582012805BLDG Active14082022-10-24
00818582010764Puracyn® Plus Professional Formula 65042022-10-18
00818582010771Puracyn® Plus Professional Formula 65162022-10-19
00818582010788Puracyn® Plus Professional Formula 65082022-10-18
00818582010856Puracyn® Plus Professional Formula 65022022-10-17
00818582010993Puracyn® Plus Professional Formula 65032022-10-18
00818582011006Puracyn® Plus Professional Formula 65052022-10-18
00818582011013Puracyn® Plus Professional Formula 65092022-10-18
00818582011020Puracyn® Plus Professional Formula 65172022-10-19
00818582011310Puracyn® Plus Professional Formula 65242022-10-19
00818582011327Puracyn® Plus Professional Formula 65252022-10-19
00818582011334Puracyn® Plus Professional Formula 65272022-10-19
00818582011723Puracyn® Plus Professional Formula 65182022-10-19
00818582012430BLDG Active14042022-10-20
00818582012553BLDG Active14052022-10-20
00818582012560BLDG Active14062022-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
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