Catalog Number

AU5632

Brand Name

V. Mueller

Version/Model Number

AU5632

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KCJ

Product Code Name

APPLICATOR, ENT

Public Device Record Key

13afbe21-a79e-4090-b314-b9cc782f70a4

Public Version Date

February 07, 2020

Public Version Number

3

DI Record Publish Date

August 02, 2018

Package DI Number

70885403181889

Quantity per Package

12

Contains DI Package

10885403008535

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-