Catalog Number

V800

Brand Name

MARTIN LEWIS G.C. SYSTEM

Version/Model Number

V800

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

20bf8bc4-0213-41ab-8629-19daa674929e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

M202V8002

Quantity per Package

12

Contains DI Package

M202V8001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box