Catalog Number

-

Brand Name

TransMotionMedical

Version/Model Number

S550

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

K152056

Product Code

INK

Product Code Name

Stretcher, Wheeled, Powered

Public Device Record Key

22933a1e-156a-4628-bb40-d78a6dd5bb3a

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

December 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-