DEVICE: Extraoral Cassette with LANEX Regular Screens (60889971002808)

Device Identifier (DI) Information

Extraoral Cassette with LANEX Regular Screens
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution
1002807
CARESTREAM HEALTH, INC.
60889971002808
GS1

1
793169512 *Terms of Use
Extraoral Cass w/ LANEX REG SCR 8x10in
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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?
34317 X-ray intensifying screen
A device typically considered to be a component of an x-ray film cassette used in diagnostic x-ray applications. It is typically used in pairs with double side emulsion x-ray film. It consists of a backing material, e.g., cardboard, plastic or metal; a reflecting layer of material, e.g., titanium dioxide; an active layer of light-emitting phosphor, e.g., calcium tungstate, barium sulfate, or rare earth material; and a protective layer, typically a plastic coating used to reduce static electricity and allow cleaning. It is used to reduce the x-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film.
Active false
35839 X-ray film cassette, automatic film changing
A housing for x-ray film specifically designed to be used in, and work as part of, an automated x-ray film changing system. The housing is intended to be loaded with x-ray film under appropriate darkroom conditions, and is then inserted into the loading magazine of the film changing system. After exposure, it is held in a receiving magazine until the operator removes it for final processing.
Active false
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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

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Size Type Text
No Device Sizes
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Device Record Status

e18ffbcf-da67-4b0b-9f7c-8d97ffb173eb
March 29, 2018
2
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
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

[?]
No Customer Contact currently defined
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