ONE TRAY® Sealed Sterilization Container

FDA UDI

Class II (US FDA UDI)

by Innovative Sterilization Techn

Identity

Trade Name: ONE TRAY® Sealed Sterilization Container FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: (L) 20.142" x (H) 8.573" x (W) 11.616" FDA UDI
Model / Reference: M2108DT FDA UDI
Description: (L) 20.142" x (H) 8.573" x (W) 11.616" FDA UDI

Identifiers

Catalog Number: M2108DT FDA UDI
Primary DI / UDI-DI: 00859522006027 FDA UDI
FDA Product Code: KCT FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

ONE TRAY® Sealed Sterilization Container by Innovative Sterilization Techn — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Innovative Sterilization Techn

Sources (1)

FDA UDI 25a7f33f-2f5e-41b8-8aa9-49d8deb7d012 34 fields · synced May 30, 2026