DEVICE: Green RE 400 Speed (05414904040102)

Device Identifier (DI) Information

Green RE 400 Speed
Green RE 400 Speed 30X35
In Commercial Distribution
EHYH4
Agfa HealthCare NV
05414904040102
GS1

1
282853795 *Terms of Use
USABS CAS US GREEN 400 30X35
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
X-ray film cassette, manual A device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system or image formatting unit and consists of a plastic or metal housing with removable metal or plastic inserts. Some film cassettes used in x-ray applications can incorporate an x-ray grid into the cassette design.
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FDA Product Code

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Product Code Product Code Name
IXA Cassette, radiographic film
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K023020 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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Width: 35 Centimeter
Length: 30 Centimeter
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Device Record Status

b54e16c1-87fe-473c-8741-f05cb79bcfbb
July 06, 2018
3
September 01, 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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(877)777-2432
salesinfo@agfa.com
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