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DIRECTVIEW CR Cassette with HR Screen

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
DIRECTVIEW CR Cassette with HR Screen FDA UDI
Generic Name
Digital imaging cassette/phosphor plate FDA UDI
Device Name
DIRECTVIEW CR Cassett with HR Scrn 18x24 FDA UDI
Model / Reference
DIRECTVIEW CR Cassette with HR Screen FDA UDI
Description
DIRECTVIEW CR Cassett with HR Scrn 18x24 FDA UDI

Identifiers

Catalog Number
1269679 FDA UDI
Primary DI / UDI-DI
40889971269672 FDA UDI
510(k) Number
K040378 FDA UDI
FDA Product Code
IXA FDA UDI
GMDN Term
Digital imaging cassette/phosphor plate FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1850 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K040378 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carestream Health, Inc.

Sources (1)

  • FDA UDI 2f9480d9-6f62-4249-b9aa-f5b3002bcde4 37 fields · synced Jun 8, 2026