Catalog Number

-

Brand Name

CTS™ OpTmizer™ T-Cell Expansion Supplement

Version/Model Number

A3747001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 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

K113566

Product Code

NDS

Product Code Name

MEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Public Device Record Key

57e34bbd-87ba-4fa1-ac0a-29a7a16b2ee8

Public Version Date

August 13, 2020

Public Version Number

6

DI Record Publish Date

June 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-