Catalog Number

800-0077-B

Brand Name

SchureMed

Version/Model Number

BERCHTOLD

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

6d5423f8-c1ae-4526-9f25-bf756d208384

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 21, 2019

Package DI Number

01081001460023

Quantity per Package

1

Contains DI Package

00810014600024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-