Catalog Number

-

Brand Name

CTS™ AIM-V™ Medium

Version/Model Number

A3830802

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

Product Code

NDS

Product Code Name

MEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Public Device Record Key

ee103741-471b-46b4-89a4-0ca0dc85d98c

Public Version Date

August 11, 2020

Public Version Number

5

DI Record Publish Date

April 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-