FDA.reportPublic FDA data

Wolf X-Ray

Primary DI
00843696119614
Brand
Wolf X-Ray
Company
Flow X Ray Corporation
Model
10011
Device description
Intensifying Screen, Detail Speed, 24 cm X 30 cm
Published
2020-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAMScreen, Intensifying, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAMScreen, Intensifying, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843696119614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843696119614008436961196148436961196140843696119614

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
010016319
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843696114312COMPRESSION PADDLE141072022-12-22
00081204503900DV-58 ADULT ECONO PAK182042023-08-09
00812045030115DX-58 ADULT PAPER PAK180012023-08-09
00812045030634DX-42 BITE CHEX180602023-08-09
00812045030832DV-57 ADULT TWIN VALUE PAK18201E2023-08-09
00812045030849DV-53 CHILD TWIN PEDO PAK18236E2023-08-09
00812045030856DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET19235E2023-08-09
00812045030863DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET19601E2023-08-09
00812045030870" DUPLICATING FILM, 14 X 17"""311762023-08-09
00812045030887DV-58 ADULT VALUE PAK182002023-08-09
00812045030894DV-57 ADULT TWIN VALUE PAK182012023-08-09
00812045030917DV-54 CHILD ECONO PAK182062023-08-09
00812045030924FV-58 ADULT ECONO PAK182152023-08-09
00812045030931DV-54 CHILD PEDO PAK182352023-08-09
00812045030948DV-53 CHILD TWIN PEDO PAK182362023-08-09
00812045030955FV-58 ADULT VALUE PAK183102023-08-09
00812045030962FV-57 ADULT TWIN VALUE PAK184102023-08-09
00812045030979DV-58 ADULT FRESH PAK186002023-08-09
00812045030986DV-57 ADULT TWIN FRESH PAK186012023-08-09
00812045030993FV-58 ADULT FRESH PAK186202023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889813062005Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
00889813062012Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
00889813062029Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062002Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062019Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062026Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
00817169023531Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024484Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024491Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024507Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024514Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024521Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169025016Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169023593Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023609Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023616Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023623Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169025009Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023586Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
40889978979543Flexible Phosphor Screen GP-2CARESTREAM HEALTH, INC.EAM2021-06-27
60889978979547Flexible Phosphor Screen GP-2CARESTREAM HEALTH, INC.EAM2021-06-27
00843696119577Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119591Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119607Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119621Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119638Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696115005Wolf X-RayFlow X Ray CorporationEAM2020-09-25
00843696115012Wolf X-RayFlow X Ray CorporationEAM2020-09-25
00843696115029Wolf X-RayFlow X Ray CorporationEAM2020-09-25
00843696115036Wolf X-RayFlow X Ray CorporationEAM2020-09-25