FDA.reportPublic FDA data

EZ-TRAX™

Primary DI
00850006159314
Brand
EZ-TRAX™
Company
K1 MEDICAL TECHNOLOGIES, LLC
Model
068 DIVIDER.2.4.15
Catalog number
068 DIVIDER.2.4.15
Device description
Divider (H) 2.4 x (L) 15
Published
2020-01-20
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
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006159314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006159314008500061593148500061593140850006159314

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
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00653159014208CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014215CASE MEDICALCase Medical Inc.KCT2026-06-08
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
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03