FDA.reportPublic FDA data

McKesson

Primary DI
40612479232486
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
186-6542
Device description
Antimicrobial Hydrogel 3oz
Published
2023-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K150799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150799000Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional FormulaInnovacyn, Inc.2015-11-19FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479232486PackageGS16In Commercial Distribution
10612479232478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247923248640612479232486
1061247923247810612479232478

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479288496McKesson16-SN1C2905ST2026-10-08
20612479288526McKesson16-SN05C2905ST2026-10-08
20612479288557McKesson16-SN1C2805ST2026-10-08
20612479288588McKesson16-SN1C2558ST2026-10-08
10612479285993McKessonEXT-STND-070-0652026-10-06
10612479286013McKessonEXT-SM-030-0802026-10-06
10612479235592McKesson16-18502020-06-10
10612479235608McKesson16-18522020-06-10
10612479258317McKesson16-18602020-06-25
10612479258348McKesson16-18622020-06-25
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08