DIRECTVIEW CR Gridded Cassette with PQ Screen

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: DIRECTVIEW CR Gridded Cassette with PQ Screen FDA UDI
Generic Name: Digital imaging cassette/phosphor plate FDA UDI
Device Name: DIRECTVIEW CR Cassett with PQ Scrn 35x35 FDA UDI
Model / Reference: DIRECTVIEW CR Gridded Cassette with PQ Screen FDA UDI
Description: DIRECTVIEW CR Cassett with PQ Scrn 35x35 FDA UDI

Identifiers

Catalog Number: 8645442 FDA UDI
Primary DI / UDI-DI: 40889978645448 FDA UDI
FDA Product Code: IXJ FDA UDI
GMDN Term: Digital imaging cassette/phosphor plate FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1910 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

Category: Digital imaging cassette/phosphor plate

DIRECTVIEW CR Gridded Cassette with PQ Screen by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Digital imaging cassette/phosphor plate.

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CR MD4.0T PLATE — Agfa Corp. · Class II
CR HD5.0 GENERAL DETECTOR — Agfa Corp. · Class II
REGIUS Cassette/Plate — Konica Minolta, Inc. · Class II
CR Reader — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Carestream Health, Inc.

Sources (1)

FDA UDI fcc00d4a-b347-43ff-bdc0-8fa1562fa42b 35 fields · synced Jun 8, 2026