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CARESTREAM CR Mammography Cassette with SNP-M1 Screen

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
CARESTREAM CR Mammography Cassette with SNP-M1 Screen FDA UDI
Generic Name
Digital imaging cassette/storage phosphor screen, mammographic FDA UDI
Device Name
CARESTREAM CR Cassette 35x43 / 14x17 FDA UDI
Model / Reference
CARESTREAM CR Mammography Cassette with SNP-M1 Screen FDA UDI
Description
CARESTREAM CR Cassette 35x43 / 14x17 FDA UDI

Identifiers

Catalog Number
1978600 FDA UDI
Primary DI / UDI-DI
60889971978608 FDA UDI
510(k) Number
K120246 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Digital imaging cassette/storage phosphor screen, mammographic

CARESTREAM CR Mammography Cassette with SNP-M1 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

K120246 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 3360be50-eebe-4511-a2fe-018402dc770e 36 fields · synced Jun 8, 2026