Catalog Number

1104

Brand Name

MUELLER HINTON w 5% SB

Version/Model Number

1104

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

26c1f412-d6b0-4861-ac49-6e160db57433

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

M20211042

Quantity per Package

10

Contains DI Package

M20211041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box