DEVICE: Half Blue X-ray Film WB (40889971088679)
Device Identifier (DI) Information
Half Blue X-ray Film WB
Half Blue X-ray Film WB
Not in Commercial Distribution
1088673
CARESTREAM HEALTH, INC.
Half Blue X-ray Film WB
Not in Commercial Distribution
1088673
CARESTREAM HEALTH, INC.
100SH 8X10IN HALF BLUE X-RAY
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
40979 | Medical x-ray film, screen |
A screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IWZ | Film, radiographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 30 and 60 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Storage Environment Humidity: between 30 and 50 Percent (%) Relative Humidity |
Handling Environment Temperature: between 4 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e9732753-9b02-471a-81d6-46aa67f1cc36
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 |
---|---|---|---|---|---|
60889971088673 | 5 | 40889971088679 | 2021-05-12 | 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:
00889971088671
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined