FUJI MEDICAL DRY FILM

Basic Information

• Brand Name: FUJI MEDICAL DRY FILM
• Primary DI: 04547410222579
• Version / Model: DI-HL 35X43 100 ==
• Catalog Number: 4741022257
• Company Name: FUJIFILM CORPORATION
• Labeler DUNS: 713565195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: 4dbabced-a492-436f-b773-1ce63c50dae9

Device Description

MEDICAL DRY IMAGING FILM 100NIF 35x43

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMC	Camera, multi format, radiological	Radiology	892.2040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14547410222576	GS1	box	5	In Commercial Distribution
Primary	04547410222579	GS1
Unit of Use	84547410222575	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K033377	000
K962967	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			35X43CM

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius