Catalog Number

-

Brand Name

STEMPROÒ MSC SFM Basal Medium CTS™

Version/Model Number

A1033401

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

-

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

-

FDA Premarket Submission

K103302,K103302

Product Code

NDS

Product Code Name

MEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Public Device Record Key

df529412-1937-41ce-b3a2-5fa1a5c620f5

Public Version Date

November 18, 2019

Public Version Number

6

DI Record Publish Date

August 01, 2016

Package DI Number

30190302005160

Quantity per Package

10

Contains DI Package

10190302005166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case