Catalog Number

790-0038

Brand Name

SchureMed

Version/Model Number

790-0038

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

FWZ

Product Code Name

Operating Room Accessories Table Tray

Public Device Record Key

1c80ff6a-7b0b-49f8-9144-2eac58e532f1

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

March 12, 2019

Package DI Number

01810014600184

Quantity per Package

1

Contains DI Package

00810014600185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-