Catalog Number

1106

Brand Name

MUELLER HINTON

Version/Model Number

1106

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

K945911,K945911,K945911

Product Code

JTZ

Product Code Name

CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Public Device Record Key

e28f0b73-3dbd-48bd-9d3d-1a92da4be511

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

M20211062

Quantity per Package

3

Contains DI Package

M20211061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box