FDA.reportPublic FDA data

NPWT Antimicrobial Large Gauze Roll

Primary DI
00040565124223
Brand
NPWT Antimicrobial Large Gauze Roll
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66800391
Catalog number
66800391
Device description
NPWT Antimicrobial Large Gauze Roll
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142979000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142979000RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX CanistersSmith & Nephew, Inc.2015-04-29OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30040565124224PackageGS110In Commercial Distribution
00040565124223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3004056512422430040565124224
00040565124223000405651242230405651242230040565124223

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Regulatory Flags#

DUNS number
216344051
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05000223503284ACTICOAT Flex66027689660276892026-08-25
05000223503697ACTICOAT Flex66027691660276912026-08-25
05000223482589CICA CARE66801491668014912026-04-30
05000223502157CICA CARE66803184668031842026-04-30
05000223502270ACTICOAT Flex66027686660276862026-04-29
05000223502300ACTICOAT Flex66027687660276872026-04-29
05000223502331ACTICOAT Flex66027688660276882026-04-29
05000223502249ACTICOAT Flex66027685660276852026-04-28
05000223502218ACTICOAT FLEX66027684660276842026-03-26
05000223503727ACTICOAT Flex66027683660276832026-03-26
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117737COVRSITE5971430059714300 / 597144002026-01-19
00040565117690COVRSITE5971400059714000 / 597141002026-01-19
00040565120249COVRSITE59715000597150002026-01-19
00040565120263COVRSITE59715100597151002026-01-19
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19
00040565120270COVRSITE59715100597151002026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084501920Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501937Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501944Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501951Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00749756985475DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985963DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985994DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756986250DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756401289DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401692DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401746DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
04719873697724NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697731NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697748NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697755NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697762NACARILEX MEDICAL, INC.OMP2026-08-26
00197998301209Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301285Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301360Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501029Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501036Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501043Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501050Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00197998301148Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998301162Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998303906Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300912Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22