FDA.reportPublic FDA data

FUJI MEDICAL X-RAY FILM

Primary DI
04547410130133
Brand
FUJI MEDICAL X-RAY FILM
Company
FUJIFILM CORPORATION
Model
SUPER HR-U 35X43 500 E **
Catalog number
4741013013
Device description
FUJI MEDICAL X-RAY FILM
Published
2022-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
14547410130130PackageGS15In Commercial Distribution
04547410130133PrimaryGS10
84547410130139Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454741013013014547410130130
04547410130133045474101301334547410130133
8454741013013984547410130139

GMDN Terms#

Term, Definition table
TermDefinition
Medical x-ray film, screenA screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. 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. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18002728465xxx@xxx.xxx

Regulatory Flags#

DUNS number
713565195
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573596212318S3ESCLSS3ESCLS2024-01-25
04573596212325S3ESELS3ESEL2021-07-18
04573596201367OASISMR-NVC-120OASIS RAPID NV Coil MR-NVC-1202026-05-29
04573596201398OASISMR-QFC-120OASIS QD Flexible Body Coil(L) MR-QFC-1202026-05-29
04573596201404OASISMR-QFC-120XLOASIS QD Flexible Body Coil(XL) MR-QFC-120XL2026-05-29
04573596201411OASISMR-RFC-120OASIS RAPID Foot Coil MR-RFC-1202026-05-29
04573596201435OASISMR-CTL-120OASIS CTL Coil MR-CTL-1202026-05-29
04573596202159OASISMR-IBC-120OASIS RAPID Breast Coil MR-IBC-1202026-05-29
04547410480269FUJIFILMVS-10002026-05-22
04547410529128FUJIFILMEG-S100XT2026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22
04573596201480APERTO LucentMR-QHC-81RQD Head coil R MR-QHC-81R for APERTO Lucent2026-05-22
04573596201497APERTO LucentMR-QKC-83RQD Knee coil R MR-QKC-83R for APERTO Lucent2026-05-22
04573596201503APERTO LucentMR-IBC-83Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H65810058710Henry ScheinHENRY SCHEIN, INC.IWZ2020-05-14