FDA.reportPublic FDA data

ONE TRAY® Sealed Sterilization Container

Primary DI
00859522006027
Brand
ONE TRAY® Sealed Sterilization Container
Company
INNOVATIVE STERILIZATION TECHN
Model
M2108DT
Catalog number
M2108DT
Device description
"(L) 20.142"" x (H) 8.573"" x (W) 11.616"""
Published
2025-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859522006027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859522006027008595220060278595220060270859522006027

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
078885794
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859522006089ONE TRAY® Sealed Sterilization ContainerM2106DTM2106DT2026-03-06
00859522006010ONE TRAY® Sealed Sterilization ContainerM2104DTM2104DT2017-08-03
00859522006157ONE TRAY® Sealed Sterilization ContainerM2408M24082016-09-24
00859522006508ONE TRAY® Sealed Sterilization ContainerASSY-21152018-08-05
00859522006515ONE TRAY® Sealed Sterilization ContainerASSY-21352018-08-05
00859522006522ONE TRAY® Sealed Sterilization ContainerASSY-24152018-08-05
00859522006539ONE TRAY® Sealed Sterilization ContainerASSY-24352018-08-05
00859522006607ONE TRAY® Sealed Sterilization ContainerASSY-21252018-08-05
00859522006614ONE TRAY® Sealed Sterilization ContainerASSY-21452018-08-05
00859522006621ONE TRAY® Sealed Sterilization ContainerASSY-24252018-08-05
00859522006638ONE TRAY® Sealed Sterilization ContainerASSY-24452018-08-05
00859522006003ONE TRAY® Sealed Sterilization ContainerOTK-BOX50OTK-BOX502025-05-12
00859522006065ONE TRAY® Sealed Sterilization ContainerOTTORANGE400OTTORANGE4002026-01-08
00859522006072ONE TRAY® Sealed Sterilization ContainerOTTGREEN400OTTGREEN4002026-01-08
00859522006034ONE TRAY® Sealed Sterilization ContainerM2404DTM2404DT2025-05-12
00859522006041ONE TRAY® Sealed Sterilization ContainerM2406DTM2406DT2025-05-12
00859522006058ONE TRAY® Sealed Sterilization ContainerM2408DTM2408DT2025-05-12
00859522006102ONE TRAY® Sealed Sterilization ContainerM21042016-09-24
00859522006119ONE TRAY® Sealed Sterilization ContainerM21062016-09-24
00859522006126ONE TRAY® Sealed Sterilization ContainerM21082016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817766026355X-Series CaseTecometKCT2026-09-04
00817766026362X-Series CaseTecometKCT2026-09-04
00817766026379X-Series CaseTecometKCT2026-09-04
00817766026386X-Series CaseTecometKCT2026-09-04
00817766026393X-Series CaseTecometKCT2026-09-04
00817766026430X-Series CaseTecometKCT2026-09-04
00817766026447X-Series CaseTecometKCT2026-09-04
00385640094146INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094153INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094160INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094177INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094139INSTRUSAFESummit Medical, Inc.KCT2026-08-26
00724995234232V. MuellerSteris CorporationKCT2026-08-26
00724995234249V. MuellerSteris CorporationKCT2026-08-26
00724995234256V. MuellerSteris CorporationKCT2026-08-26
00724995234263V. MuellerSteris CorporationKCT2026-08-26
00724995234270V. MuellerSteris CorporationKCT2026-08-26
00724995234287V. MuellerSteris CorporationKCT2026-08-26
00724995234294V. MuellerSteris CorporationKCT2026-08-26
00724995234300V. MuellerSteris CorporationKCT2026-08-26
00724995234317V. MuellerSteris CorporationKCT2026-08-26
00724995234324V. MuellerSteris CorporationKCT2026-08-26
00724995234331V. MuellerSteris CorporationKCT2026-08-26
00724995234348V. MuellerSteris CorporationKCT2026-08-26
00724995234355V. MuellerSteris CorporationKCT2026-08-26
00724995234362V. MuellerSteris CorporationKCT2026-08-26
00724995234379V. MuellerSteris CorporationKCT2026-08-26
00724995234386V. MuellerSteris CorporationKCT2026-08-26
00724995234393V. MuellerSteris CorporationKCT2026-08-26
00724995234409V. MuellerSteris CorporationKCT2026-08-26