BK-200 - SHIMADZU CORPORATION

Duns Number:690558747

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More Product Details

Catalog Number

-

Brand Name

BK-200

Version/Model Number

566-16404-50

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)

-

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

IXQ

Product Code Name

Table, Radiographic, Stationary Top

Device Record Status

Public Device Record Key

a7f2aa44-fb96-471b-894f-f00ad03cc04f

Public Version Date

April 13, 2020

Public Version Number

1

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHIMADZU CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 192
2 A medical device with a moderate to high risk that requires special controls. 242