← Back to catalogue

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen FDA UDI
Generic Name
Digital imaging cassette/storage phosphor screen, mammographic FDA UDI
Device Name
18X24CM CR MAMMO SCR EHR-M3 FDA UDI
Model / Reference
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen FDA UDI
Description
18X24CM CR MAMMO SCR EHR-M3 FDA UDI

Identifiers

Catalog Number
8336190 FDA UDI
Primary DI / UDI-DI
40889978336193 FDA UDI
PMA Number
P080018 FDA UDI
FDA Product Code
MUE FDA UDI
GMDN Term
Digital imaging cassette/storage phosphor screen, mammographic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1715 FDA UDI
Commercial Distribution
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

Yes

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

Category: Digital imaging cassette/storage phosphor screen, mammographic

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Digital imaging cassette/storage phosphor screen, mammographic.

Cleared under the same submission

P080018 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Carestream Health, Inc.

Sources (1)

  • FDA UDI 69643b2e-0240-4b1f-883f-e15345029f46 36 fields · synced Jun 8, 2026