Catalog Number

800-0081-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

Yes

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

07d92c4e-7f16-498d-bf27-684587ea612b

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 22, 2019

Package DI Number

01810014600047

Quantity per Package

1

Contains DI Package

00810014600048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-