DEVICE: DIRECTVIEW CR Cassette with HR Screen (40889971269672)

Device Identifier (DI) Information

DIRECTVIEW CR Cassette with HR Screen
DIRECTVIEW CR Cassette with HR Screen
Not in Commercial Distribution
1269679
CARESTREAM HEALTH, INC.
40889971269672
GS1
March 15, 2018
1
793169512 *Terms of Use
DIRECTVIEW CR Cassett with HR Scrn 18x24
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
44824 Digital imaging cassette/phosphor plate
A device that includes both a digital imaging cassette and a phosphor plate (also known as screen) intended to receive radiation by a diagnostic x-ray system, to record a patient radiation pattern during a non-dental procedure. The device is then transferred, with the cassette shielding the plate from environmental light, to a computed radiography (CR) scanner for insertion to produce the digital image of the patient. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IXA Cassette, radiographic film
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K040378 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

2f9480d9-6f62-4249-b9aa-f5b3002bcde4
June 19, 2024
5
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
60889971269676 5 40889971269672 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

[?]
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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