AccessGUDID - DEVICE: XRpad Digital X-Ray Detector System (00812589020085)

GUDID

Device Identifier (DI) Information

Brand Name: XRpad Digital X-Ray Detector System
Version or Model: XRpad 4343 F MED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 95510935-02
Company Name: Perkinelmer, Inc.

Primary DI Number: 00812589020085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623897670 *Terms of Use

Device Description: The PerkinElmer XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 18.7 million pixel image matrix, a best-in-class 100 μm pixel pitch, and a direct deposited CsI scintillator, the PerkinElmer XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration.

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?
60265	Flat panel x-ray detector integration unit	A portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a digital x-ray system (retrofit) using the same modality components. It is typically an electronic box which is integrated into the analogue x-ray system via wired connections to each of the components (i.e., generator, exposure button, workstation and detector), whereby it synchronizes the original analogue generator with the direct flat panel detector.	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 [?]
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 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Weight: 4.1 Kilogram
Width: 460 Millimeter
Length: 460 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: 7dab0691-300c-4dcd-9a95-afe640c17c59
Public Version Date: February 21, 2019
Public Version Number: 3
DI Record Publish Date: July 29, 2016