Catalog Number

23129

Brand Name

STR COVER-5X31X76-2 TAPERED-FITS BOTH CFT/STD FOAM-CAL117-POLYURETHANE

Version/Model Number

SMC-53176-2T-UF117-PU

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

-

Product Code

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Public Device Record Key

3bb32dd1-81ee-46e2-a11e-d003f502cd42

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-