Catalog Number

MTSBRT034

Brand Name

Rail Button

Version/Model Number

MTSBRT034

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K973842

Product Code

IXQ

Product Code Name

Table, radiographic, stationary top

Public Device Record Key

b174e013-c14d-4a48-9c58-21f98c2b46f4

Public Version Date

March 02, 2020

Public Version Number

6

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-