Trinias - SHIMADZU CORPORATION

Duns Number:690558747

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More Product Details

Catalog Number

-

Brand Name

Trinias

Version/Model Number

503-79402-31

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

Yes

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

-

FDA Premarket Submission

K123508

Product Code Details

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Device Record Status

Public Device Record Key

c2e6708d-840c-42e8-8da1-f04b0b69c4d9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 10, 2016

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