Catalog Number

1737

Brand Name

JEMBEC MARTIN LEWIS

Version/Model Number

1737

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

K950196,K950196,K950196

Product Code

JTY

Product Code Name

CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Public Device Record Key

3ff03e5f-3352-4065-a6af-5e2fdc9f26af

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

M20217372

Quantity per Package

10

Contains DI Package

M20217371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box