AccessGUDID - DEVICE: Xplorer 1600 Plus Digital Radiographic System (00823073051010)

GUDID

Device Identifier (DI) Information

Brand Name: Xplorer 1600 Plus Digital Radiographic System
Version or Model: 1600 X4C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Imaging Dynamics Company Ltd

Primary DI Number: 00823073051010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252909973 *Terms of Use

Device Description: Digital Radiographic System

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):	No
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)
KPR	System, x-ray, stationary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between -40 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 324 Kilogram
Length: 2450 Millimeter
Device Size Text, specify: Length of the Column
Width: 1550 Millimeter
Device Size Text, specify: Width of the Column
Device Size Text, specify: Height of the Column
Device Size Text, specify: Weight of the Column
Height: 2645 Millimeter

Device Record Status

Public Device Record Key: 9e8fb3cd-e19d-42cd-a7d2-034b47c64d41
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 26, 2017