Catalog Number

-

Brand Name

GenASIs™ System

Version/Model Number

GenASIs

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 21, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140957,K122554,K110345,K012103,K101291,K071398,K050236

Product Code

JOY

Product Code Name

Device, Automated Cell-Locating

Public Device Record Key

b1693f20-471e-4e7d-9581-5c4800a4d0b9

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

January 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-