DEVICE: DIRECTVIEW CR Mammography Cassette with EHR-M Screen (40889971508276)

Device Identifier (DI) Information

DIRECTVIEW CR Mammography Cassette with EHR-M Screen
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution
1508274
CARESTREAM HEALTH, INC.
40889971508276
GS1
March 15, 2018
1
793169512 *Terms of Use
DIRECTVW CR Mammo Cass EHR-M Scrn 18x24
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44825 Digital imaging cassette/storage phosphor screen, mammographic
A combination device for mammography applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic mammography x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the mammography x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
MUE Full field digital,system,x-ray,mammographic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P080018 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 24 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a2825555-a512-4e12-99b4-fbacf59ed92e
July 06, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
60889971508270 4 40889971508276 2018-03-13 Not in Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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