FDA.reportPublic FDA data

ONE TRAY® Sealed Sterilization Container

Primary DI
00859522006010
Brand
ONE TRAY® Sealed Sterilization Container
Company
INNOVATIVE STERILIZATION TECHN
Model
M2104DT
Catalog number
M2104DT
Device description
"(L) 20.142"" x (H) 4.573"" x (W) 11.616"""
Published
2017-08-03
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052567000ONE TRAY SEALED STERILIZATION CONTAINERSterile Containment Technology, LLC2006-03-13KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859522006010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859522006010008595220060108595220060100859522006010

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, reusableA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078885794
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859522006089ONE TRAY® Sealed Sterilization ContainerM2106DTM2106DT2026-03-06
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
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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