RF 11X14 Sensor Panel - DR-PANEL-LT1114-L / R - KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Duns Number:080269345

Device Description: DR-PANEL-LT1114-L / R

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More Product Details

Catalog Number

-

Brand Name

RF 11X14 Sensor Panel

Version/Model Number

PAN292

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MQB

Product Code Name

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device Record Status

Public Device Record Key

629c1777-8729-405e-949c-3eb1d262811f

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

April 30, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KONICA MINOLTA MEDICAL IMAGING U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 44