DEVICE: Oncology EC Film (40889978855724)
Device Identifier (DI) Information
Oncology EC Film
Oncology EC Film
Not in Commercial Distribution
8855728
CARESTREAM HEALTH, INC.
Oncology EC Film
Not in Commercial Distribution
8855728
CARESTREAM HEALTH, INC.
Oncology EC Film 11X14in 100SH
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? |
---|---|---|---|---|
40980 | Medical x-ray film, non-screen |
A non-screen x-ray film specifically designed for use in medical imaging applications. Non-screen x-ray film is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. 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.
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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 |
---|
Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Storage Environment Humidity: between 30 and 50 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0456b17e-ee05-4c66-a05f-d3f11e0cd66c
November 08, 2021
3
September 16, 2016
November 08, 2021
3
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 |
---|---|---|---|---|---|
60889978855728 | 5 | 40889978855724 | 2021-11-04 | Not in Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00889978855726
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined