AccessGUDID - DEVICE: FUJI MEDICAL DRY FILM (04547410222579)

GUDID

Device Identifier (DI) Information

Brand Name: FUJI MEDICAL DRY FILM
Version or Model: DI-HL 35X43 100 ==
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4741022257
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410222579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 713565195 *Terms of Use

Device Description: MEDICAL DRY IMAGING FILM 100NIF 35x43

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35580	Diagnostic-imaging multiformat camera	An electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMC	Camera, multi format, radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033377	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 25 Degrees Celsius
Handling Environment Humidity: between 30 and 60 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 35X43CM

Device Record Status

Public Device Record Key: 4dbabced-a492-436f-b773-1ce63c50dae9
Public Version Date: May 30, 2024
Public Version Number: 5
DI Record Publish Date: September 16, 2016