Catalog Number

-

Brand Name

STEMPROÒ MSC SFM Supplement CTS™

Version/Model Number

A1033301

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2020

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

35641563-3b79-4f60-bb99-493e5442b540

Public Version Date

August 11, 2020

Public Version Number

7

DI Record Publish Date

August 01, 2016

Package DI Number

30190302005153

Quantity per Package

20

Contains DI Package

10190302005159

Package Discontinue Date

August 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Case