Catalog Number

10-8000

Brand Name

InTray™ GC

Version/Model Number

1080

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K993033,K993033,K993033,K993033

Product Code

JTY

Product Code Name

Culture Media, For Isolation Of Pathogenic Neisseria

Public Device Record Key

baeb33b4-58fa-41da-87f0-6e6f3ba1dc3f

Public Version Date

July 18, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

B08810804

Quantity per Package

20

Contains DI Package

B08810800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box