FDA.reportPublic FDA data

MIN-R 2 Cassette with MIN-R EV 150 Screen

Primary DI
60889971117038
Brand
MIN-R 2 Cassette with MIN-R EV 150 Screen
Company
CARESTREAM HEALTH, INC.
Model
MIN-R 2 Cassette with MIN-R EV 150 Screen
Catalog number
1117035
Device description
18X24CM MIN-R2 CASS W/EV 150 SCR
Published
2016-09-16
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
false

Product Codes#

Code, Name table
CodeName
IXACassette, radiographic film

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXACassette, Radiographic FilmRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971117038PackageGS16In Commercial Distribution
40889971117034PrimaryGS10
00889971117036Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6088997111703860889971117038
4088997111703440889971117034
00889971117036008899711170368899711170360889971117036

GMDN Terms#

Term, Definition table
TermDefinition
X-ray intensifying screenA device typically considered to be a component of an x-ray film cassette used in diagnostic x-ray applications. It is typically used in pairs with double side emulsion x-ray film. It consists of a backing material, e.g., cardboard, plastic or metal; a reflecting layer of material, e.g., titanium dioxide; an active layer of light-emitting phosphor, e.g., calcium tungstate, barium sulfate, or rare earth material; and a protective layer, typically a plastic coating used to reduce static electricity and allow cleaning. It is used to reduce the x-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793169512
Device count
150
DM exempt
false
Premarket exempt
false
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
00850077007293Huestis Medical Flexi-HolderHUESTIS MACHINE CORPORATIONIXA2025-03-05
05055449402958KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449413992KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449415927KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449415989KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
00810106410432dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410449dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410456dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410463dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410470dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410487dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410494dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410500dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410517dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410524dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410531dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410548dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410555dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410562dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410579dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410418dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-04
00810106410425dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-04
60889971033574DIRECTVIEW CR Long-Length Cassette with PQ ScreenCARESTREAM HEALTH, INC.IXA2021-06-06
00810050241236N/ADOMICO MED-DEVICE, LLCIXA2020-09-24
00810050240994NADOMICO MED-DEVICE, LLCIXA2020-09-24
60889978607334MIN-R 2 Cassette with MIN-R 2190 ScreenCARESTREAM HEALTH, INC.IXA2017-11-07
08809413810198Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810228Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810235Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810242Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01