FDA.reportPublic FDA data

Oncology EC Film

Primary DI
40889978855724
Brand
Oncology EC Film
Company
CARESTREAM HEALTH, INC.
Model
Oncology EC Film
Catalog number
8855728
Device description
Oncology EC Film 11X14in 100SH
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IWZFilm, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWZFilm, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889978855728PackageGS15Not in Commercial Distribution
40889978855724PrimaryGS10
00889978855726Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6088997885572860889978855728
4088997885572440889978855724
00889978855726008899788557268899788557260889978855726

GMDN Terms#

Term, Definition table
TermDefinition
Medical x-ray film, non-screenA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Regulatory Flags#

DUNS number
793169512
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889971739193DRX-Evolution Plus SystemDRX-Evolution Plus System17391922016-09-16
60889978007257DRX-Revolution Mobile X-ray SystemDRX-Revolution Mobile X-ray System80072542016-09-16
60889976565667CARESTREAM DRX-EVOLUTIONCARESTREAM DRX-EVOLUTION65656672016-09-16
40889971067506CS 7200CS 720010675032016-09-16
40889971067513CS 7200CS 720010675112016-09-16
40889971337227CS 7400CS 740013372292016-09-16
40889978214231CS 7400CS 740082142312016-09-16
40889978427969CS 7400CS 740084279652016-09-16
40889978666948CS 7400CS 740086669432016-09-16
60889976579336Vita Flex CR SystemVita Flex CR System65793382019-08-03
60889976579343Vita Flex CR SystemVita Flex CR System65793462019-08-03
60889976579367Vita Flex CR SystemVita Flex CR System65793612019-08-03
60889971746337Vita Flex CR Long Length Imaging SystemVita Flex CR Long Length Imaging System17463382020-05-25
60889971006240Vita LE CR SystemVita LE CR System10062462016-09-16
60889971014306CS 7600CS 760010143072016-09-16
60889971014313CS 7600CS 760010143152016-09-16
60889971023704CS 7600 SLOT PANELCS 7600 SLOT PANEL10237042016-09-16
60889971023711CS 7600 SLOT PANELCS 7600 SLOT PANEL10237122016-09-16
60889971024084Vita CR SystemVita CR System10240822016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06430035873371OCCLUSAL 4C KIT SCAN EXAMPaloDEx Group OyIWZ2026-06-22
10810050855843Rad ControlTYPENEX MEDICAL LLCIWZ2026-05-06
06430035874637Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874644Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874651Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874668Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874675Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874682Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874699Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874705Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874996Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875009Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875016Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875023Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875030Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875047Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875054Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875061Imaging PlatesPaloDEx Group OyIWZ2024-02-22
40889971051260D-SpeedCARESTREAM HEALTH, INC.IWZ2022-01-11
40889971463117Medical X-ray Green / MXG FilmCARESTREAM HEALTH, INC.IWZ2021-05-30
H65811253101Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-18
H65811253331Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-18
H65890042830Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042840Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042850Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042860Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042870Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042880Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042890Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65810012430Henry ScheinHENRY SCHEIN, INC.IWZ2020-05-14