Catalog Number

800-0039

Brand Name

SchureMed

Version/Model Number

800-0039

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 09, 2019

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

2af344c3-0580-41b1-9f67-8e27a9b3c502

Public Version Date

September 09, 2021

Public Version Number

3

DI Record Publish Date

February 21, 2019

Package DI Number

01810014600153

Quantity per Package

1

Contains DI Package

00810014600154

Package Discontinue Date

September 09, 2019

Package Status

Not in Commercial Distribution

Package Type

-