Catalog Number

508-0373

Brand Name

SchureMed

Version/Model Number

508-0373

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 02, 2021

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

b83e5eff-5dfa-4aa8-98e9-8aa581deb3d1

Public Version Date

September 03, 2021

Public Version Number

3

DI Record Publish Date

March 13, 2019

Package DI Number

01810014600108

Quantity per Package

1

Contains DI Package

00810014600109

Package Discontinue Date

September 02, 2021

Package Status

Not in Commercial Distribution

Package Type

-