FDA.reportPublic FDA data

Ez Trax

Primary DI
00850006159017
Brand
Ez Trax
Company
K1 MEDICAL TECHNOLOGIES, LLC
Model
LID.AL.12.12
Catalog number
061 LID.ASSY.AL.12.12
Device description
Lid Aluminum (L)12 (W)12
Published
2019-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006159017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006159017008500061590178500061590170850006159017

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. 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
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
00889795135278Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
00888867504059Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504066Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504073Arthrex®ARTHREX, INC.FSM2026-09-21
00749756400800DeRoyalDEROYAL INDUSTRIES, INC.FSM2026-09-18
08800037575166ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
10888857252820DENALI® Spinal SystemVB Spine LLCFSM2026-08-28
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
00724995296230V. MuellerSteris CorporationFSM2026-08-21
10888857596740NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596757NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596764NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596771NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596788NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596795NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596801NAPA Access SystemVB Spine LLCFSM2026-07-31