FDA.reportPublic FDA data

Ez Trax

Primary DI
00850006159055
Brand
Ez Trax
Company
K1 MEDICAL TECHNOLOGIES, LLC
Model
059 INSERT.AL.21.12.2
Catalog number
059 INSERT.AL.21.12.2
Device description
Insert Aluminum (L)21 (W)12 (H)2
Published
2019-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850006159055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006159055008500061590558500061590550850006159055

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

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