FDA.reportPublic FDA data

EZ Trax

Primary DI
00850041479019
Brand
EZ Trax
Company
K1 MEDICAL TECHNOLOGIES, LLC
Model
175 ID Plate
Catalog number
175 ID Plate
Device description
ID Plate
Published
2024-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192487000EZ-TRAX Containment DeviceK1 Medical, LLC2019-12-23KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041479019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041479019008500414790198500414790190850041479019

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080448429
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041479163EZ Trax202 Pin Caddy w/Lid 7.5.1.5.1.5202 Pin Caddy w/Lid 7.5.1.5.1.52025-12-12
00850025473088EZ-TRAX™125 BRACKETINSERTFRAMEASSY-AL-2.4.-1.550125 BRACKETINSERTFRAMEASSY-AL-2.4.-1.5502021-02-16
00850025473132EZ-TRAX™121 LID.ASSY.AL.20.11121 LID.ASSY.AL.20.112021-02-23
00850025473149EZ-TRAX™123 LID.ASSY.AL.25.12123 LID.ASSY.AL.25.122021-02-23
00850025473019EZ-TRAX™102 POST.1PC.172102 POST.1PC.1722021-02-13
00850025473057EZ-TRAX™116 BRACKET-AL-H2.0-SZ20-P116116 BRACKET-AL-H2.0-SZ20-P1162021-02-13
00850025473002EZ-TRAX™105 BRACKETASSY.BROACH.SZ5105 BRACKETASSY.BROACH.SZ52021-02-07
00850025473026EZ-TRAX™107 BRACKETASSY.BROACH.SZ6107 BRACKETASSY.BROACH.SZ62021-02-07
00850006159185EZ-TRAX™068 DIVIDER.2.4.02068 DIVIDER.2.4.022020-01-20
00850006159567EZ-TRAX™084 MMT.THA.REAMERS084 MMT.THA.REAMERS2020-01-20
00850006159574EZ-TRAX™085 MMT.THA.BROACHBASE085 MMT.THA.BROACHBASE2020-01-20
00850006159239EZ-TRAX™068 DIVIDER.2.4.07068 DIVIDER.2.4.072021-05-17
00850006159253EZ-TRAX™068 DIVIDER.2.4.09068 DIVIDER.2.4.092021-05-17
00850006159277EZ-TRAX™068 DIVIDER.2.4.11068 DIVIDER.2.4.112021-05-17
00850006159291EZ-TRAX™068 DIVIDER.2.4.13068 DIVIDER.2.4.132021-05-17
00850006159321EZ-TRAX™068 DIVIDER.2.4.16068 DIVIDER.2.4.162021-05-17
00850006159338EZ-TRAX™068 DIVIDER.2.4.17068 DIVIDER.2.4.172021-05-17
00850006159345EZ-TRAX™068 DIVIDER.2.4.18068 DIVIDER.2.4.182021-05-17
00850006159352EZ-TRAX™068 DIVIDER.2.4.19068 DIVIDER.2.4.192021-05-17
00850006159215EZ-TRAX™068 DIVIDER.2.4.05068 DIVIDER.2.4.052020-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00653159014222CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014239CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23