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Mark3

FDA UDI

Class I (US FDA UDI)

by Cargus International, Inc

Identity

Trade Name
MARK3 FDA UDI
Generic Name
Dental material mixing surface, chairside, single-use FDA UDI
Device Name
Mixing Pad 3" x 3" 50 Sheets - MARK3®* FDA UDI
Model / Reference
8584 FDA UDI
Description
Mixing Pad 3" x 3" 50 Sheets - MARK3®* FDA UDI

Identifiers

Catalog Number
8584 FDA UDI
Primary DI / UDI-DI
D79685841 FDA UDI
FDA Product Code
NRD FDA UDI
GMDN Term
Dental material mixing surface, chairside, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental material mixing surface, chairside, single-use

Mark3 by Cargus International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material mixing surface, chairside, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cargus International, Inc

Sources (1)

  • FDA UDI 61b42eda-7048-4635-89c3-2e9952faf483 35 fields · synced May 29, 2026