DEVICE: DIRECTVIEW CR Mammography Cassette with EHR-M Screen (40889971290386)
Device Identifier (DI) Information
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution
1290386
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution
1290386
CARESTREAM HEALTH, INC.
DIRECTVW CR Mammo Cass EHR-M2 Scrn 18x24
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.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MUE | Full field digital,system,x-ray,mammographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P080018 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f295b42c-cc8d-436a-b365-bd252d04651f
May 14, 2021
4
September 16, 2016
May 14, 2021
4
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
60889971290380 | 5 | 40889971290386 | 2021-05-11 | Not in Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined