DEVICE: DIRECTVIEW CR Mammography Cassette with HR Screen (60889971650511)

Device Identifier (DI) Information

DIRECTVIEW CR Mammography Cassette with HR Screen
DIRECTVIEW CR Mammography Cassette with HR Screen
Not in Commercial Distribution
1650514
CARESTREAM HEALTH, INC.
60889971650511
GS1
March 15, 2018
1
793169512 *Terms of Use
DIRECTVIEW CR Cassett with HR Scrn 24x30
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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

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

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Size Type Text
No Device Sizes
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Device Record Status

567037f3-0da4-4fdd-b7d1-f7278e005442
July 06, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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