FDA.reportPublic FDA data

EB/RA Film

Primary DI
60889971577504
Brand
EB/RA Film
Company
CARESTREAM HEALTH, INC.
Model
EB/RA Film
Catalog number
1577501
Device description
100SH 8X10 EB/RA 4153
Published
2017-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
60889971577504PackageGS15In Commercial Distribution
40889971577500PrimaryGS10
00889971577502Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6088997157750460889971577504
4088997157750040889971577500
00889971577502008899715775028899715775020889971577502

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793169512
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810106411040Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411057Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411064Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411071Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411088Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411095Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411101Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411118Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
D678734701Plate Transfer BoxAIR TECHNIQUES, INC.IWZ2025-09-05
00810050855457Rad ControlTYPENEX MEDICAL LLCIWZ2025-05-23
00810050855471Rad ControlTYPENEX MEDICAL LLCIWZ2025-05-23
00810106410937Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2025-01-28
00810106410944Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2025-01-28
00810106410920Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-12-30
00810106410913Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-11-21
00810106410906Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-11-11
05060608881512Precision Cut GafChromic™ FilmSUN NUCLEAR CORP.IWZ2024-11-01
00810106410869Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410876Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410883Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410890Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410852Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-22
00810106410814Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810106410821Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810106410838Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810050855648Rad ControlTYPENEX MEDICAL LLCIWZ2024-07-15
00810106410791Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-06-04
00810106410760Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-05-17
00810106410777Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-05-17
00810106410784Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-05-17