Catalog Number

MTS9230

Brand Name

MTS

Version/Model Number

MTS9230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

BK920013

Product Code

KSG

Product Code Name

MEDIA, POTENTIATING FOR IN VITRO DIAGNOSTIC USE

Public Device Record Key

9d4a3eb7-6f49-458c-8962-04b33d0779c0

Public Version Date

December 20, 2018

Public Version Number

4

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-