Ez-Trax™

FDA UDI

Class II (US FDA UDI)

by K1 Medical Technologies, Llc

Identity

Trade Name: EZ-TRAX™ FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: Divider (H) 2.4 x (L) 05 FDA UDI
Model / Reference: 068 DIVIDER.2.4.05 FDA UDI
Description: Divider (H) 2.4 x (L) 05 FDA UDI

Identifiers

Catalog Number: 068 DIVIDER.2.4.05 FDA UDI
Primary DI / UDI-DI: 00850006159215 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

Yes

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

Ez-Trax™ by K1 Medical Technologies, Llc — 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: K1 Medical Technologies, Llc

Sources (1)

FDA UDI 0c71096f-ee0a-4c67-be85-6f476658eb0a 34 fields · synced May 30, 2026