Catalog Number

B91240

Brand Name

Navios EX

Version/Model Number

TETRA SOFTWARE V2.0 NEW USER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K162897

Product Code

OYE

Product Code Name

Flow Cytometric Reagents And Accessories.

Public Device Record Key

4595d7f2-ca24-40af-be33-5aa79172ab8b

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

July 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-