Catalog Number

ED2-1

Brand Name

V. Mueller

Version/Model Number

ED2-1

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K844652

Product Code

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

ff58600d-32bb-488e-ba8d-a6a688384d2d

Public Version Date

July 08, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-