Catalog Number

107 BRACKETASSY.BROACH.SZ6

Brand Name

EZ-TRAX™

Version/Model Number

107 BRACKETASSY.BROACH.SZ6

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"

Yes

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

FSM

Product Code Name

Tray, Surgical, Instrument

Public Device Record Key

be1e59b1-654a-441d-9e19-2a66c7d45ae2

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

February 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-