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Mark3

FDA UDI

Class I (US FDA UDI)

by Cargus International, Inc

Identity

Trade Name
MARK3 FDA UDI
Generic Name
Laboratory instrument/analyser absorbent liner IVD FDA UDI
Device Name
Tray Covers White Ritter B 8-1/2" x 12-1/4" 1,000/cs. - MARK3 FDA UDI
Model / Reference
1330WH FDA UDI
Description
Tray Covers White Ritter B 8-1/2" x 12-1/4" 1,000/cs. - MARK3 FDA UDI

Identifiers

Primary DI / UDI-DI
D7961330WH0 FDA UDI
FDA Product Code
NRD FDA UDI
GMDN Term
Laboratory instrument/analyser absorbent liner IVD 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

Yes

FDA UDI

Category: Laboratory instrument/analyser absorbent liner IVD

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

Similar devices

Also classified as Laboratory instrument/analyser absorbent liner IVD.

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 d823d46e-4855-44c1-95e4-dcd4605461e7 34 fields · synced May 30, 2026