FDA.reportPublic FDA data

ONE TRAY® Sealed Sterilization Container

Primary DI
00859522006072
Brand
ONE TRAY® Sealed Sterilization Container
Company
INNOVATIVE STERILIZATION TECHN
Model
OTTGREEN400
Catalog number
OTTGREEN400
Published
2026-01-08
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859522006072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859522006072008595220060728595220060720859522006072

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

Regulatory Flags#

DUNS number
078885794
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00859522006027ONE TRAY® Sealed Sterilization ContainerM2108DTM2108DT2025-05-12
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

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Primary DI, Brand, Company table
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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
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