Catalog Number

800-0164

Brand Name

SchureMed

Version/Model Number

539-0019 and 539-0018

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

Yes

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

FWZ

Product Code Name

Operating Room Accessories Table Tray

Public Device Record Key

6bdd1d1e-b087-4554-84f5-3128bae5751e

Public Version Date

March 20, 2019

Public Version Number

1

DI Record Publish Date

March 12, 2019

Package DI Number

01810014600177

Quantity per Package

1

Contains DI Package

00810014600178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-