Catalog Number

MTIL6027

Brand Name

Universal Couchtop™

Version/Model Number

MTIL6027

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180021

Product Code

IXQ

Product Code Name

Table, radiographic, stationary top

Public Device Record Key

c08fde8e-091c-45e1-a26c-7bb9d2ea098b

Public Version Date

June 06, 2022

Public Version Number

1

DI Record Publish Date

May 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-