Catalog Number

RM-ASY-04823

Brand Name

Trident Specimen Radiography System

Version/Model Number

RM-ASY-04823

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K111508

Product Code

MWP

Product Code Name

Cabinet,x-ray system

Public Device Record Key

c7086347-b98b-4b98-b463-ab24f95ce5b0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-