FDA.reportPublic FDA data

Medical X-ray Cassette with Green 400 Screens

Primary DI
60889976807101
Brand
Medical X-ray Cassette with Green 400 Screens
Company
CARESTREAM HEALTH, INC.
Model
Medical X-ray Cassette with Green 400 Screens
Catalog number
6807101
Device description
10X12IN MX CASS W/GREEN 400 SCREEN
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896708000PERLINK CASSETTE, KIRAN CASSETTEPerlink USA, Inc.1990-05-07IXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889976807101PackageGS15In Commercial Distribution
40889976807107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997680710160889976807101
4088997680710740889976807107

GMDN Terms#

Term, Definition table
TermDefinition
X-ray film cassette, automatic film changingA housing for x-ray film specifically designed to be used in, and work as part of, an automated x-ray film changing system. The housing is intended to be loaded with x-ray film under appropriate darkroom conditions, and is then inserted into the loading magazine of the film changing system. After exposure, it is held in a receiving magazine until the operator removes it for final processing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793169512
Device count
1
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