FDA.reportPublic FDA data

Tzoar

Primary DI
00850017034143
Brand
Tzoar
Company
LIGHTSTONE MEDICAL LLC
Model
LSM-SQ-1010
Device description
Tzoar NPWT OPD - Square 1010
Published
2023-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K202898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202898000Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.2021-12-30OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850017034140PackageGS15In Commercial Distribution
20850017034147PackageGS14In Commercial Distribution
00850017034143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001703414010850017034140
2085001703414720850017034147
00850017034143008500170341438500170341430850017034143

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system pump, electricA mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).

Regulatory Flags#

DUNS number
126892971
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017034013TzoarLSM-KL2023-10-06
00850017034020TzoarLSM-KM2023-10-06
00850017034037TzoarLSM-KS2023-10-06
00850017034044TzoarLSM-D2023-10-06
00850017034051TzoarLSM-IN-22072023-10-06
00850017034068TzoarLSM-LO-14102023-10-06
00850017034075TzoarLSM-SQ-15152023-10-06
00850017034082TzoarLSM-SC-13122023-10-06
00850017034099TzoarLSM-SO-10082023-10-06
00850017034105TzoarLSM-SQ-20202023-10-06
00850017034174TzoarLSM-C4002023-10-06
00850017034006TzoarLSM-2072023-10-06
10850017034010TzoarLSM-KL2023-10-06
10850017034027TzoarLSM-KM2023-10-06
10850017034034TzoarLSM-KS2023-10-06
10850017034041TzoarLSM-D2023-10-06
10850017034058TzoarLSM-IN-22072023-10-06
10850017034065TzoarLSM-LO-14102023-10-06
10850017034072TzoarLSM-SQ-15152023-10-06
10850017034089TzoarLSM-SC-13122023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00197998300936Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00840117350984Durma+ Flexible Suction Bell, With TubingDynarex CorporationOMP2026-06-22
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
08718104890947Endo-SPONGE PumpMeditop B.V.OMP2025-10-17
00197998028922Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998028946Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998032608Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998312267Solventum US LLCKCI USA, INC.OMP2025-07-29
10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14