Catalog Number

-

Brand Name

GIBCO® CTS™ AIM V® SFM

Version/Model Number

0870112DK

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

K022086,K022086

Product Code

NDS

Product Code Name

MEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Public Device Record Key

bbbef1c3-e498-412a-a2a5-a7a1a989cf4a

Public Version Date

August 11, 2020

Public Version Number

6

DI Record Publish Date

August 01, 2016

Package DI Number

30190302005092

Quantity per Package

6

Contains DI Package

10190302005098

Package Discontinue Date

August 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Case