Catalog Number

IN110

Brand Name

Image Navigator®

Version/Model Number

IN110

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

PIV

Product Code Name

Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Public Device Record Key

2423c793-cc8b-409f-9048-2b16457afcb2

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

April 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-