AccessGUDID - DEVICE: FDR ES C43 (04547410361377)

GUDID

Device Identifier (DI) Information

Brand Name: FDR ES C43
Version or Model: DR-ID 1274 SE E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410361377
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 713565195 *Terms of Use

Device Description: The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.

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:	No
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?
37645	Stationary basic diagnostic x-ray system, digital	An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid state x-ray imager (flat panel/digital imager)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142003	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
Handling Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -30 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 460x460x15mm

Device Record Status

Public Device Record Key: 88ea27d5-5e1a-458e-a032-347046779278
Public Version Date: May 30, 2024
Public Version Number: 4
DI Record Publish Date: February 05, 2018