Catalog Number

AU14320001

Brand Name

V. Mueller

Version/Model Number

AU14320001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 07, 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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JYH

Product Code Name

EXCAVATOR, EAR

Public Device Record Key

f01bf457-26bc-4f13-9451-1a631b283247

Public Version Date

March 04, 2022

Public Version Number

2

DI Record Publish Date

July 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-